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International device safety notices

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Continuing the International device safety notices list, 1000 records per page.

  1. Safety Notice for the Brilliance series 6, 16, 40, 64, CT Big Bore, iCT and iCT SP CT…
  2. Urgent Field Safety Notice for Optilite Analyser by The Binding Site Group Limited
  3. Recall for the sterile Teflon Tube T2 Humerus, Stryker Osteosynthesis
  4. Corrective action for Advia 2120/2120i, Advia Autoslide, Siemens
  5. Urgent Field Safety Notice for T2 Arthrodesis / Femur / Tibia / Recon / Greater Trochanter…
  6. Information about correct handling of „Danis Procedure Pack“ and „Danis Procedure Pack…
  7. Urgent Field Safety Notice for Linx Reflux Management System by Torax Medical Inc
  8. Urgent Field Safety Notice for Medtronic MiniMed 640G Insulin Pump by Medtronic Minimed
  9. Lot Recall of the tibial broach Foundation, DJO Surgical
  10. Safety Notice for the Norland Illuminatus DXA Software with the DICOM Option…
  11. Urgent Field Safety Notice for T-Cell Select by Oxford Immunotec Ltd.
  12. Urgent Field Safety Notice for Spiros by ICU Medical Inc.
  13. DUET TRS Universal Straight and Articulating Single Use Loading Units
  14. Urgent Field Safety Notice for Vitality Spinal Fixation System by Zimmer Biomet Spine, Inc
  15. Recall for the Leucocytic Permeabilization Reagent, Beckman Coulter
  16. Urgent field safety notice for RIA Estradiol Kit PN A21854, Immunotech s.r.o. / Beckman…
  17. Urgent Field Safety Notice for MIC* Gastric-Jejunal Feeding Tube by Avanos Medical Inc
  18. Corrective Action for AQT90 FLEX Analyzers, Radiometer
  19. Lot recall of PT Owren’s GHI131-10 SI, MediRox AB
  20. Urgent Field Safety Notice for Koaxiale Interventionelle Kanüle / Coaxial Interventional…
  21. Urgent Field Safety Notice for Mölnlycke Procedure Trays & Detachable EndoRetrieval Pouch…
  22. Urgent Field Safety Notice for Halbautomatische Biopsiekanüle by ITP Innovative Tomography…
  23. Safety Notice for the Triathlon Tibial Alignment Handle und Nav Tibial Alignment Handle…
  24. Corrective action for Calcium CPC, Dialab
  25. Safety Notice for PET/CT systems GEMINI TF16, TF64 und TF Big Bore, Philips
  26. Urgent Field Safety Notice for CyberKnife Robotic Radiosurgery System by Accuray…
  27. CareLink Programmer
  28. Corrective action for the IMMULITE® 2000/IMMULITE® 2000 XPi Marjoram allergen, Siemens…
  29. Urgent Field Safety Notice for Rhinomer Hypertonic 20ml by Laboratoire de la Mer
  30. Urgent Field Safety Notice for ProcedurePak trays containing specific i.e. codes and…
  31. Artis system equipped with a large display
  32. TARGET 360 SOFT 6.0MM X 15CM
  33. CEREC AC / AF / AI with Omnicam
  34. ORTHO VISION Max Analyzer for ORTHO BioVue Cassettes
  35. Dimension Thyroid Stimulating Hormone
  36. Reflotron PST Hemoglobin 30str.
  37. NucliSENS easyMAG Lysis Buffer
  38. IH-1000
  39. 074c4c51-ee1a-e118-4027-18ee3127b232
  40. NeoCoil
  41. Human Care Hanger-Bar HeliQ - tootmisvea tõttu keermeliim peale kandmata, võimalik puuduv…
  42. Interactive Precision IO Scan Adapter. FSN 1, Interactive Precision IO Scan Adapter. FSN 2
  43. 448a773d-012b-e67c-5c22-30b54860058a
  44. Randox HbA1c Calibrator Set
  45. Posterior Fluidics Module for Stellaris PC Vision Enhancement System
  46. aa7c18e8-976b-9a39-1410-44a5b93fe618
  47. LFIT Anatomic CoCr V40 Femoral Heads
  48. Externes Ventrikeldrainageset mit Platte und Klemme
  49. MyPTM App
  50. RapiD 20 E
  51. Stealth, Surgical Spring Clip
  52. Light probe Pin-Point 6 > 2 mm, black (Style)
  53. Prisma, Prismaflex, Prismars, X-mars, Adsorba, Septex and Oxiris sets - Priority 2…
  54. VIDAS TB-IGRA
  55. Automatic AQC Cartridge
  56. Alinity s HIV Ag/Ab Combo Reagent Kit
  57. NEXGEN Complete Knee Solution Distal Femoral Resection Guide
  58. astraia software for women's health
  59. Abbott Alinity m HBV Assay - võimalikud valekõrged tulemused proovide vahelise ülekande…
  60. ALFApump System
  61. Novo XS 4
  62. Aisys
  63. Philips Medical Systems DMC GmbH Essenta DR Compact - andmete võimalik mitteühildumine
  64. M525 F40 Surgical Microscopes
  65. Maquet Critical Care AB Servo-n - HFOV piiratud jõudlus
  66. DigitalDiagnost
  67. TherMax Blood Warmer Unit
  68. 0f5a122e-2b4d-c463-23cf-f1097885b84b
  69. Nitinol TC Reusable Electrodes
  70. ca0a1f6b-0b9e-6883-06fa-66f53d6a6a00
  71. AUTOGEN CRT-D & AUTOGEN DR ICD
  72. Pentaray® NAV Catheter; Pentaray® NAV eco Catheter
  73. Safety Corrective Action regarding EXCOR arterial cannula with graft CGRG-021, Berlin…
  74. Urgent Field Safety Notice for Extreme H20 59 Xtra by Clerio Vision
  75. Lot Recall of the Acufex Director Elite ACL Drill Guide System Tray, Smith & Nephew
  76. Corrective action for the Sapphire Infusion Pump, Q Core Medical
  77. Urgent Field Safety Notice for Plasmasammelflasche by Heinz Meise GmbH Medizintechnik
  78. Urgent Field Safety Notice for OEC Elite by GE OEC Medical Systems, Inc.
  79. Urgent Field Safety Notice for Rhinomer isotonic 20ml by Laboratoire de la Mer
  80. Safety Notice concerning the Walker Etac ONO, Etac
  81. Access Immunoassay Systems Thyroglobulin Antibody, Model/Catalog 33890
  82. Urgent field safety notice for Multiplate Analyzer, Roche
  83. Lot recall of Cortex Screw Ø 2.7 mm (self-tapping), DePuy Synthes
  84. DxI 9000 Access Immunoassay Analyzer
  85. Corrective action for the ADVIA® Chemistry Systems A1c_3 calibrator, Siemens Healthcare…
  86. Urgent field safety notice for Human Milk Analyser, MIRIS AB
  87. Urgent Field Safety Notice for Novation Calcar Planer Guide Tip by EXACTECH, Inc.
  88. Safety issue associated with use of GE Centricity Critical Care numeric entry fields, GE…
  89. Urgent Field Safety Notice for Atellica UAS 800 analyzer by Siemens Healthcare Diagnostics…
  90. Safety Notice for mobile X-ray units Endura, Pulsera and Veradius, Philips
  91. Optilite Analyser
  92. Urgent Field Safety Notice for Hamilton-C6 by Hamilton Medical AG
  93. Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology, Brilliance CT 16 (Air)
  94. Urgent Field Safety Notice for BeGraft Peripheral Plus Stent Graft System by Bentley…
  95. Urgent Field Safety Notice for Pharmagel Breast pads, GEL7075 by Pharmaplast S.A.E.
  96. Urgent Field Safety Notice for ADVIA 2120/2120i Hematology System by Siemens Healthcare…
  97. Safety Notice for Pentax EG-3870UTK Ultrasound video endoscope
  98. Urgent field safety notice for 2M implacross E head, Implantcast
  99. Corrective action for the MicroScan LabPro Information Manager System, Beckman Coulter
  100. Urgent Field Safety Notice for ADVIA 2120/2120i Hematology System by Siemens Healthcare…
  101. ON-Q C-bloc ONDEMAND
  102. Safety Notice concerning VMX and VMX Plus Mobile X-ray systems, GE Healthcare
  103. Lot Recall for Lupine Loop Anchor, DePuy
  104. Safety Notice concerning missing reprocessing references in the instruction manual of…
  105. Potential inaccuracy of BrainSCAN Pencil Beam Dose Algorithm, Brainlab AG
  106. Lot Recall for the Cutisoft Cotton Gauze Swabs, BSN Medical
  107. Safety Notice for Hemodraw® Closed Blood Sampling System, Smiths Medical
  108. Safety Notice concerning MR290 Autofeed Humidification Chambers, Fisher & Paykel
  109. Urgent Field Safety Notice for IMAGEnet 6 by Topcon Corporation
  110. Urgent field safety notice for TECOTHERM NEO, TEC COM GmbH
  111. Recall for EBV EBNA-1-IgG-ELISA PKS medac, Medac GmbH
  112. Urgent Field Safety Notice for BEGO Semados SC 3,25 L13 by BEGO Implant Systems GmbH & Co…
  113. Safety Notice for the Portnoy Ventricular Catheter, Integra NeuroSciences
  114. Urgent Field Safety Notice for Infusion s.t., transfusion s.t. and associated accessories…
  115. Software correction for Perimeter Octopus 900 with Flash Software Version V 2.1.4 and V…
  116. Issue with Mosaiq upon import of treatment plan, Elekta
  117. Urgent Safety Notice for the Relay and Relay NBS Thoracic Stent-Graft Systems, Bolton…
  118. Recall (Phase 2) of the Trabecular Metal™ Reverse Glenosphere Distractor, Zimmer Inc.
  119. Recall of Milenia Biotec for Milenia QuickLine HIT, Milenia Biotec
  120. Additional safety and warning information concerning Acetocaustin, Temmler Pharma
  121. Safety Information about the Auto-Fetch functionality of the Centricity PACS-IW system, GE…
  122. Urgent Field Safety Notice for Werber Countersink Cannulated for micro CBS screws by…
  123. Urgent Field Safety Notice for MultiDiagnost Eleva + MultiDiagnost Eleva mit Flachdetektor…
  124. Batch recall of Legion HK bolt and sleeve, Smith & Nephew Inc.
  125. Safety Notice for Mobile Monitoring Gateway (MMG) and Cardiomax, Ascom AB
  126. Urgent Field Safety Notice for Logic Fit Tibial Tamp Head Instrument by EXACTECH, Inc.
  127. Urgent Field Safety Notice for Equinoxe Modular and No.-Modular Pilot Tip Reamers by…
  128. Safety Notice for the Philips Essenta DR Compact, Philips Medical Systems
  129. Corrective action for the m2000sp E-series Instrument and m24sp Instrument,
  130. Urgent Field Safety Notice for Care set Obstetrics (0001) - Kocher forceps by PAUL…
  131. Corrective action for the MicroScan® Microbiology Systems / MicroScan Dried Gram Negative…
  132. Corrective action for the cotton-tipped applicators with polypropylene grip, Paul Hartmann…
  133. Urgent Field Safety Notice for Alinity c Cuvette Segment by Abbott GmbH & Co. KG
  134. Recall for AngioJet® Thrombectomy Sets, Boston Scientific International S.A.
  135. Safety Notice for Washer / disinfector (endoscope disinfection unit), Steris
  136. Recall of several T-Piece Resuscitation Circuits, GE Healthcare Clinical Systems
  137. Information for daVinci System, Intuitive Surgical
  138. Corrective action for the TRIGEN 8/7 mm x 24 cm Humeral Nail, Smith & Nephew Inc.
  139. Urgent Field Safety Notice for Occlutech Delivery Set by Occlutech GmbH
  140. Safety Notice for Linet Image, Eleganza E3 and Eleganza E3XC bedframes: Replacement of…
  141. Urgent field safety notice for TWINFIX QUICK-T KNOT PUSHER SUTURE CUTTERS, Smith and…
  142. Urgent Field Safety Notice for da Vinci Xi and da Vinci X Surgical System by Intuitive…
  143. Safety Notice for Phaco I/A Tubing Cassette Quicksets, Carl Zeiss Meditec AG
  144. Field Safety Notice for Ellipse VR/DR, St. Jude Medical
  145. Urgent field safety notice for Dimension Vista System / Dimension Vista Creatinine (CRE2)…
  146. Urgent Field Safety Notice for Vision C by Visaris d.o.o.
  147. Recall of temporary transvenous pacing lead system Model 6416-100 / 6416-140 / 6416-200…
  148. Recall of VITROS Calibrator Kit 24, Ortho Clinical Diagnostics
  149. Corrective action for HemosIL AcuStar HIT-Ab(PF4-H), Instrumentation Laboratory
  150. Urgent field safety notice for Access Free T3 Reagent Kit, Beckman Coulter Inc.
  151. Lot recall of SOLIS Trial Cage, STRYKER
  152. Recall of Sorbsan Calcium Alginate Dressings (Flat, Ribbon, Packing, Plus and Border) and…
  153. Urgent Field Safety Notice for Organ Care System (OCS) Heart by TransMedics, Inc.
  154. Urgent Field Safety Notice for Ingenia Ambition S und Ingenia Ambition X by Philips…
  155. Video endoscopic equipment with accessories: surgical generator 400 KHz: control unit…
  156. Urgent Safety Notice for the TraumaDiagnost systems, Philips Medical Systems
  157. Recall for Terumo® AL6X Arterial Blood Line Filter - Terumo Tubing Sets, Terumo
  158. Urgent Field Safety Notice for SYRINGE TIP CAP by Baxter Healthcare Corporation (Colorado)
  159. Recall of Ambulatory Blood Pressure (ABP) Monitor, Spacelabs Healthcare
  160. Urgent Field Safety Notice for Bacillus cereus Medium (MYP) by Oxoid Deutschland GmbH
  161. Corrective action for the product Nit-Occlud Implantation Sheath, pfm medical mepro gmbh
  162. Safety Notice for the OR table integration TEGRIS OR TABLE CONTROL, MAQUET GmbH
  163. Urgent Safety Notice for the product Tibiagelenkteil, Pol-Endo - size small and medium /…
  164. Urgent Field Safety Notice for Activa Clinician Programmer Application by Medtronic Inc
  165. Further Safety Information for the TomoTherapy Treatment System, Accuray
  166. Lot recall of cannulated screw 3.5 mm, aap Implantate AG
  167. Urgent Field Safety Notice for LYNDA + Amplya Acute Multitherapeutic System by Bellco…
  168. Safety Notice for the Cavitron® Inserts, DENTSPLY DETREY GmbH
  169. Corrective action for the TomoTherapy Treatment System, Accuray
  170. Urgent field safety notice for Mueller Hinton +5% horse blood + 20 mg / l beta-NAD (MH-F)…
  171. Recall of the Symplicity® Catheter (Model RDN006), Medtronic
  172. Urgent Field Safety Notice for KLS Martin / smartDrive by Gebrüder Martin GmbH & Co. KG
  173. Corrective measures expanded for Vacutainers, Becton Dickinson
  174. Safety Notice concerning the use of the DURA-GUARD, PERI-GUARD, and VASCU-GUARD products…
  175. Safety Information: Combination Mygo/Discovery when used as a seat in a vehicle, Otto Bock
  176. Urgent Field Safety Notice for Drug-Screen Multi 3XA , Multi 8XA, Multi 9XA, BZD by nal…
  177. Urgent Field Safety Notice for Liver Assist, Kidney Assist, Lung Assist by Organ Assist
  178. Batch recall of NOVOSYN VIOLET 1 (4) 90CM HR40S, B. Braun Surgical S.A. / Braun Melsungen…
  179. Urgent Field Safety Notice for QUANTIA RF by Biokit S. A.
  180. Corrective Action for Dimension Vista V-LYTE fluids, Siemens Healthcare
  181. Urgent Field Safety Notice for Mentype AMLplexQS by Biotype Diagnostic GmbH
  182. Safety Notice concerning the Infant Ventilator Leoni Plus, Heinen + Löwenstein
  183. Urgent Field Safety Notice for Activa Clinician Programmer Application by Medtronic Inc
  184. Improper scaling of referene CT images in 3D Match environment of OBI 1.3, OBI 1.4, OBI…
  185. Urgent field safety notice for Discovery MR750w, GE Healthcare
  186. Urgent Field Safety Notice for Adapter Optiloc for handpiece, length 26mm by Valoc AG
  187. Urgent Field Safety Notice for Detektion von Neisseria gonorroeae (NG) mittels qPCR by…
  188. Recall of the ALFN Reamer, Synthes
  189. Product Batch Recall for Strauß hollow needles, Dispomed Witt oHG
  190. Urgent Field Safety Notice for SOMATOM GO.UP and SOMATOM go.Now by Siemens Shanghai…
  191. Urgent Field Safety Notice for Farabeuf Clamp for 3.5mm Screws PRO by Stryker GmbH
  192. Updated Safety Information for COGNIS® CRT-Ds and TELIGEN® ICDs, Boston Scientific
  193. Urgent Field Safety Notice for DRX-Revolution Mobile X-Ray System by Carestream Health…
  194. Urgent Safety Notice for the use of the Agility™ and Apex™-Systems, Elekta
  195. Urgent Field Safety Notice for CU 3-51 und CU 3-55 by Möller-Wedel GmbH & Co. KG
  196. Urgent Field Safety Notice for Tempus Pro by Remote Diagnostic Techologies Ltd
  197. Urgent Field Safety Notice for Access EPO Reagent by Beckman Coulter, Inc.
  198. Recall for BD GeneOhm VanR - Assay, BD Gene Ohm Cdiff - Assay and BD Gene Ohm MRSA ACP…
  199. Recall of the viscoelastic MediHeal, Mediconsult Intraocular GmbH
  200. Safety Notice for the Epilor Loss of Resistance Syringe, Becton Dickinson
  201. Corrective action for the Philips G60 patient monitor, Philips Goldway (Shenzhen)…
  202. Recall for the SPIDER® Flexible Clip Applier, TransEnterix
  203. Corrective action for the ADVIA Centaur® XPT System, Siemens Healthcare Diagnostics
  204. Lot Recall of the Hemorrhoidal Circular Stapler Proximate PPH (Product Code PPH01 and…
  205. Peripheral Interventional Products: Flexor® Check-Flo® Sheath
  206. Urgent Field Safety Notice for CoreHipTrial Neck, CoreHip Primary Calcar Cutting Guide by…
  207. Safety information for the 17-key Echo-Screen Plus device, Natus Europe GmbH
  208. Urgent Field Safety Notice for LX3 Microscope Floor Stand by Alcon Laboratories, Inc.
  209. Urgent Field Safety Notice for Anti-ß2-Glykoprotein ELISA (IgAGM) by EUROIMMUN…
  210. Urgent Field Safety Notification for Siaretron 1000 IPER Ventilator, SIARE ENGINEERING…
  211. Urgent Field Safety Notice for proANP ELISA by Biomedica Medizinprodukte GmbH & Co KG
  212. Urgent Field Safety Notice for SIMVIEW NT, SIMVIEW 3000 by Siemens AG Healthcare…
  213. CIRS BIOS and RAID Firmware update for CT systems, Philips
  214. Safety Notice for the Digital Linear Accelerators/Update for the syngo RT Therapist™…
  215. Urgent Safety Notice for the DigitalDiagnost 4.1/4.1.1, Philips Medical Systems
  216. Urgent Field Safety Notice for Artis zee/Q/Q.zen systems by Siemens Healthcare GmbH…
  217. Urgent field safety notice for DAC UNIVERSAL MKIII, Sirona Dental A/S
  218. Urgent Field Safety Notice for BOND Detection (various), Bond Instruments by Leica…
  219. Urgent Field Safety Notice for Aquilion Serve by Canon Medical Systems Corporation
  220. Urgent Safety Notice for the Dimension Vista® Systems Chemistry 1 Calibrator, Siemens…
  221. Corrective action for the product B·R·A·H·M·S Calcitonin RIA, B•R•A•H•M•S GmbH
  222. Urgent Field Safety Notice for Infant/Child SMART Pads Cartridge Adult SMART Pads by…
  223. Recall NEFA FS, DiaSys Diagnostic Systems GmbH
  224. Urgent Field Safety Notice for Reprocessable surgical instruments by Mattes Instrumente…
  225. Urgent Field Safety Notice for Colleague; Colleague 3 by Baxter Healthcare S. (Opfikon)
  226. Urgent Field Safety Notice for MX40 Intellivue by Philips Medical Systems
  227. Software Update required for Innova 2121IQ and Innova 3131IQ X-ray systems, GE Healthcare
  228. Corrective action for Easy Link Data Management Systems, Siemens
  229. Urgent field safety notice for Columbia III Agar with 5 % Sheep Blood, BD Biosciences / BD…
  230. Urgent Field Safety Notice for SBK Cut Biopsy Needle / MS-cut by Angiomed GmbH & Co…
  231. Urgent Field Safety Notice for NI-C311 Energy Hybrid Knie by Nabtesco Corporation
  232. Urgent Field Safety Notice for Samsung XGEO GC80 DR-System by SAMSUNG ELECTRONICS Co…
  233. Urgent Field Safety Notice for Neonatal ArcticGel Pads for Arctic Sun by Medivance, Inc.
  234. Corrective Action for ADVIA Centaur and ADVIA Centaur XP Multi Diluent 1, Siemens
  235. Urgent Field Safety Notice for ARTIS pheno by Siemens Healthcare GmbH; Business Area…
  236. Recall of specific lots of the EnVision™ FLEX/HRP visualization reagent, Dako
  237. Safety Information on Patient Labels for Zimmer Products manufactured before March 2010…
  238. Urgent Field Safety Notice for SureTyper Software by Linkage Biosciences, Inc.
  239. Urgent Field Safety Notice for Disposable (Semi-)Automatic Biopsy Gun by Möller Medical…
  240. Safety Notice for the syngo.plaza, Siemens Healthcare
  241. !
  242. Recall for the E1-Tapered 10° Liner 32/39, Biomet
  243. Urgent Field Safety Notice for EOS system by EOS imaging
  244. Lot Recall for AsidLine 75, Asid Bonz GmbH
  245. Urgent Field Safety Notice for Creatinine (Enzymatic) by SENTINEL CH. SpA
  246. Lot Recall for Super Sheath and Super Sheath R/O Introducer Sheaths, Boston Scientific
  247. Urgent Field Safety Notice for Askina Calgitrol Paste, Askina Gel by B. Braun Melsungen…
  248. Urgent Safety Notice / Lot Recall for Bivona Neonatal, Pediatric and Flextend Tracheostomy…
  249. Corrective action for the Discovery XR656 wall stand system having part numbers…
  250. Corrective action for the ADVIA Centaur Systems Folate Ascorbic Acid/Ascorbic Acid…
  251. Urgent Field Safety Notice for MagNA Pure 24 System by Roche Diagnostics GmbH
  252. Corrective Action for BD Retic-Count Reagent (Lot-No.: 03847), Becton Dickinson
  253. Urgent Field Safety Notice for PODOLOG MOON PROFESSIONAL by Hellmut Ruck GmbH
  254. Safety Notice for Mathys Hinge Knee, Mathys AG
  255. Urgent Field Safety Notice for Cardica C-Port xA & Flex-A PLUS Anastomosis System by…
  256. Safety Notice for the Respironics V60 ventilator, Philips
  257. Recall for the wireless Remote Control option of Practix 360 X-ray system, Philips
  258. Corrective action for Indiko, Indiko Plus, Gallery, Gallery Plus und Gallery Plus Beer…
  259. GELITA-SPON POWDER
  260. Corrective action for Cobas Integra 800 Software Version 9864.C2, Roche
  261. Lot Recall for FMS Duo+ and FMS Solo surgical irrigation tubing sets, DePuy Synthes
  262. Corrective action for Immulite / Immulite 1000, Immulite 2000 / Immulite 2000 XPI Free T3…
  263. Urgent Field Safety Notice for Zurpaz Steerable Sheath Set by Creganna Tactx Medical…
  264. Recall of HER2 CISH pharmDx Kits - Code SK 109 - Lot no. 20031665, Dako Denmark A/S
  265. Urgent Field Safety Notice for Phoenix Tibia Nail, 3.5 mm Inserter Connector by Biomet…
  266. Corrective action for TANGO optimo system, Bio-Rad Medical Diagnostics
  267. Corrective action for Oxoid Ready Poured Plate Helicobacter pylori Selective Agar, Thermo…
  268. Urgent Safety Notice for FreeStyle® Blood Glucose Test Strips, EurimPharm
  269. Lot Recall of a syringe, Pluradent AG & Co. KG
  270. Urgent Field Safety Notice for SmartPerfusion OWB; 2D Perfusion OWB by Philips Medical…
  271. Recall of LigaSure™ Dolphin tip sealer/divider Instruments (LS1500 and LS1520), COVIDIEN
  272. Recall for LIFECODES PAK 12, PAKAUTO, PAKPLUS & PAK2-LE, Gen-Probe
  273. CoreValve Evolut PRO Transcatheter Aortic Valve
  274. Urgent Field Safety Notice for Dimension Gentamicin , Dimension Vista Gentamicin by…
  275. Urgent field safety notice for Brilliance 64 / Ingenuity CT / Ingenuity Core /…
  276. Recall of normed TWIST DRILL cannulated / normed-V-TEK TWIST DRILL cannulated, Zimmer…
  277. Lot recall of PRO-PICC / PRO-LINE, Medcomp
  278. Safety Notice for Hospital Beds manufactured by the former company Arnold, Hill Rom
  279. Urgent Field Safety Notice for 4 Fr EverlinQ EndoAVF System by TVA Medical, Inc.
  280. Urgent Field Safety Notice for Aleutian AN (Anatomically Narrow) Lordotic Spread by…
  281. Urgent Field Safety Notice for UNI SCORE tibial tray for fixed bearing insert by Amplitude…
  282. Recall for the product Single-Use Gas Filter, mtp medical technical promotion GmbH
  283. Corrective action for Acrobat V & SUV Vacuum Off-Pump Systems and Xpose 3 & 4 Access…
  284. Urgent Safety Notice concerning the Scherbak weights for the Scherbak vaginal specula…
  285. Urgent Field Safety Notice for s.a..safe Catheter Extension Luer-Lock variants by…
  286. Urgent Safety Notice for Optima XR220amx, Optima XR200amx and Brivo XR285amx mobile X-ray…
  287. Urgent Safety Notice for the MICTEC Hook electrode, DUFNER Instrumente GmbH
  288. Lot recall of Enamel Plus HFO/HRi compules, Schütz Dental GmbH
  289. Safety Notice for Syringe pump A600S, CODAN ARGUS AG
  290. Urgent Field Safety Notice for AEROtube® - LK02-GB-M by Surgimax Instruments
  291. Recall of all Aspirex S embolectomy catheter sets, Straub Medical AG
  292. Urgent Field Safety Notice for Trauma Implants by Zimmer Inc.
  293. Abbott Alinity c rida tooteid - fibrinogeeni mõju EDTA tüüpi proovidele
  294. Field Safety Notice for CARDIOHELP-i, Maquet
  295. Urgent Field Safety Notice for TAPES by Endo Tools Therapeutics SA
  296. Safety Notice for the Cranial Navigation System - Standard Cranial Reference Array…
  297. Corrective action for the 4D Integrated Treatment Console, Varian Medical Systems
  298. Urgent Field Safety Notice for Pall "Ultipor" 100 Breathing System Filter by Pall Medical
  299. Urgent Field Safety Notice for 2.5 ADAPTIVE II TriLock DistRad.Pl Vol L by Medartis AG
  300. Urgent Field Safety Notice for JiveX by VISUS Technology Transfer GmbH
  301. Safety Notice for the General Purpose Sensor, CIVICO Medical Solutions
  302. Urgent Field Safety Notice for PreciControl Universal by Roche Diagnostics GmbH
  303. Urgent Field Safety Notice for PARI NaCl Inhalationslösung by PARI GmbH
  304. Urgent Field Safety Notice for Cios Alpha & Cios Spion by Siemens Healthcare GmbH Advanced…
  305. Urgent Field Safety Notice for ORTHO Vision & Vision Max Analyzer by Ortho Clinical…
  306. Urgent Safety Notice for the multifitrate acute renal replacement therapy system with…
  307. Corrective action for Medfusion Stopcocks, Smiths Medical
  308. AddOn
  309. Urgent Field Safety Notice for EXALT Model D Single-Use Duodenoscope by Boston Scientific…
  310. Safety Notice for the Femoral Segments - Endo-Model® SL® Rotational and Hinge Knee…
  311. Urgent Field Safety Notice for Accu-Chek Aviva, Aviva Plus, Performa, SmartView, and…
  312. Urgent Field Safety Notice for HSO Safeheat Wärmehandschuh, by MSP Medizintechnik GmbH
  313. Lot Recall for the Targon PF Nail, AESCULAP
  314. Urgent Field Safety Notice for Irrigation Handle by Beaver Visitec International, Inc.
  315. Urgent Safety Notice for the Application Instrument for Sternal ZipFix™, Synthes GmbH
  316. TERUMO TWO-PARTS HYPODERMIC SYRINGE
  317. Recall of Proximal Tibial Spacers made of Tilastan, Waldemar Link GmbH & Co. KG
  318. Urgent Field Safety Notice for Primedic HeartSave AED by Metrax GmbH
  319. Lot Recall of the surgical glove Sempermed Supreme, Lohmann & Rauscher
  320. Urgent field safety notice for perfusion system / heater cooler 1T / heater cooler 3T and…
  321. Urgent Field Safety Notice for EV1000 Clinical Platform System by Edwards Lifesciences LLC
  322. Urgent field safety notice for Femoral Nail A/R Ø 11x280, Stryker Trauma GmbH
  323. Urgent Field Safety Notice for RADspeed Series (Pro/CH-200/CH-200M) by Shimadzu…
  324. Urgent field safety notice for Sara Combilizer, ArjoHuntleigh / Getinge Group
  325. Urgent Field Safety Notice for PRECISION Spinal Cord Stimulator (SCS) System and VerciseT…
  326. FLOW-i
  327. Recall of Lilliput Pediatric Oxygenator Mounting Brackets / Avant & Primo2x Families Adult…
  328. Corrective action for Xevo TQ-S Mass Spectrometers, Waters
  329. Urgent field safety notice for DBS Pocket Adaptor Models 64001 and 64002, Medtronic
  330. Corrective Action for the HALOFLEX Energy Generator, BARRX Medical, Inc.
  331. Battery for Dell Computer Modell D505 (Accessory for ROTEG05 and ROTEM Gamma)
  332. Advantage Workstation
  333. NIM Eclipse System
  334. ProSet Intrafix SafeSet
  335. Olympus Medical Systems Corporation Thunderbeat Type – S - uuendus, tagasikutsumine…
  336. Bag for UV treatment of blood cells
  337. Corrective action for Artis systems, Siemens Healthcare
  338. Urgent Field Safety Notice for Aluminum Dewars by Chart Inc.
  339. Safety Notice for the Navios Flow Cytometry Software, Beckman Coulter
  340. FSN for the insert-augments of the CombiCup R System, Waldemar Link
  341. Urgent Field Safety Notice for Endo GIA Articulating Loading Units by Covidien llc
  342. Urgent field safety notice for ETD 4 endoscope washer disinfector, Miele & Cie. KG /…
  343. Urgent Field Safety Notice for Modular Stem cylindrical by Waldemar Link GmbH & Co. KG
  344. Urgent field safety notice for multifunctional bed XRCISE STRESS ECHO MED, ERGO-FIT GmbH &…
  345. Corrective Action for ROTOFIX 32A, Hettrich
  346. Urgent Field Safety Notice for Cios Alpha & Cios Spion by Siemens Healthcare GmbH Advanced…
  347. Urgent Field Safety Notice for ATTUNE Revision LPS Insert;DePuy ATTUNE Total Knee by DePuy…
  348. Safety Notice for the HD120 MLC multileaf collimator, including C-Series and True-Beam…
  349. Urgent Field Safety Notice for Artis icono and Artis pheno by Siemens Healthcare GmbH…
  350. Recall of BellaTek Zirconia-Abutments, BIOMET 3i
  351. Urgent Field Safety Notice for EVOLUT PRO PLUS, EVOLUT FX, EVOLUT FX PLUS by Medtronic…
  352. Urgent Field Safety Notice for Impella CP, Impella 5.5, Impella RP, Impella 5.0 by ABIOMED…
  353. Corrective action for BacT / Alert FA Plus Culture Bottles, BioMerieux
  354. Safety Notice for Artis Zee / Zeego systems, Siemens Healthcare
  355. Urgent Field Safety Notice for INTEGO by Sirona Dental Systems GmbH
  356. Urgent Field Safety Notice for AXS Universal Aspiration Tubing by Medela AG
  357. Lot Recall of the blood collection stopcock ArterioGuard, Codan pvb Critical Care GmbH
  358. Urgent Field Safety Notice for PROLENE Polypropyl. Suture; NUROLON Nylon Suture by Ethicon…
  359. Urgent Field Safety Notice for Assurity, Endurity by Abbott Sylmar
  360. Urgent Field Safety Notice for Artis Systems in conjunction with the Artis table by…
  361. Urgent Field Safety Notice for Tibial Opening Wedge Osteotomy Plate, Titanium, 15 by…
  362. Urgent Field Safety Notice for Infinity Acute Care System (IACS) by Draeger Medical…
  363. Urgent Field Safety Notice for Nextra Hammertoe Correction System by Nextremity Solutions…
  364. Safety Notice for a peritoneal dialysis set with a catheter adaptor manufactured by…
  365. Urgent Field Safety Notice for Infusomat compact plus by B. Braun Melsungen AG…
  366. Urgent Safety Notice for MultiDiagnost Eleva systems with flat detector, Philips…
  367. Urgent Field Safety Notice for Solero MTA System and Solero MTA Applicator by…
  368. Urgent Safety Notice for the IntelliSpace Portal Software Versions 5 and 6, Philips…
  369. Dimension Vista Gyclosporine (CSAE) Flex reagent cartridge
  370. Safety Notice for the AcSelerate DR System, Fujifilm
  371. Corrective action for the IntelliSpace PACS 4.4 software, Philips Healthcare
  372. Urgent Field Safety Notice for Arterial Cannula by Maquet Cardiopulmonary GmbH
  373. Urgent Field Safety Notice for Intubation ORAL/NASAL Endotracheal Tube by ICU Medical Inc
  374. Corrective action for the ADVIA Centaur®/ADVIA Centaur® XP Immunoassay systems, Siemens…
  375. Lot recall of Accu-Chek Insight Tender infusion set, Roche Diabetes Care
  376. Recall of Gastrotop Sump Drainage Set (product code 38710140), C. R. Bard GmbH
  377. Recall of ACHILLON minimally invasive Achilles tendon suture system, NEWDEAL SAS / lntegra…
  378. Recall for the Torque Wrench XIA3-Mantis Redux-Specialty Audible, Stryker Spine Bordeaux
  379. Recall of several dental implants, Biomet 3i
  380. Lot recall of CORE Suction Irrigation Handpieces, CONMED Corporation
  381. ulrich GmbH & Co. KG: Urgent Safety Notice for the uCentum™ comprehensive posterior system…
  382. Batch recall of SAFIL QUI+ UNDY 5/0 (1) 45 cm DSMP13, B. Braun Surgical S.A.
  383. Recall for UniCel DxI Immunoassay Systems, Beckman Coulter
  384. Recall for specific lots of the Zimmer Natural-Knee® Patella Bushings, Zimmer, Inc.
  385. Urgent Field Safety Notice for ABL9 by Radiometer Medical ApS
  386. Safety Notice for the Eclipse™ Treatment Planning System, Eclipse™ Treatment Planning…
  387. Corrective action for the Puritan Bennett™ 980 Series Ventilator System (Universal and…
  388. Batch recall of OptraPol / Tetric N-Ceram System Kit A2/N Univ. 6g / Telio CS C&B Starter…
  389. Recall of further catalogue and batch numbers of the Cuticell Classic Paraffin Gauze, BSN…
  390. Recall of all rHead and uHead stem implants, SBI
  391. Urgent Field Safety Notice for Nebulizer NebuTech Model Number 8960-7-50, Salter Labs /…
  392. Urgent Field Safety Notice for SAM XT Extremity Tourniquet by SAM Medical Products
  393. Recall for SafeSheath® CSG® Coronary Sinus Guide Braided Core Hemostatic Introducer…
  394. Corrective action for Advia 1200, 1650, 1800 and 2400 Chemistry Systems, Siemens
  395. Recall for the Insufflation hose, silicone, XION GmbH
  396. Recall for Detachable Rongeurs, Aesculap AG
  397. Corrective action for the ADVIA Centaur® and ADVIA Centaur® XP Immunoassay systems…
  398. De Puy Synthes: Recall for the Socket hexagonal, Ø 4.0/11.0 mm, cannulated
  399. Urgent field safety notice for TAPERLOC HIP LATERALISED PC STEM 15.0 / 17.5 mm 12/14…
  400. Lot recall of AutoPlex System, Stryker
  401. Field Safety Notice concerning a corrective action of the electrocardiogram (ECG)…
  402. Corrective action for the Philips Ingenuity TF PET/MR system, Philips Healthcare
  403. Urgent Field Safety Notice for Miller und Fogarty Ballonatrioseptostomie-Katheter by…
  404. Urgent Field Safety Notice for ACLELITE/ACL ELITEPRO/ACLElite Ref/ACLElitePro by…
  405. Recall of PHIL (Precipitating Embolic Injectable liquid) Non-Adhesive Liquid Embolic…
  406. Urgent Field Safety Notice for Olympus EVIS DUODENOVIDEOSCOPE PJF-240 by Olympus Medical…
  407. Recall of DGP-HP High-Power single use grounding pads and Cool-tip™ RFA Electrode Kits…
  408. Lot recall of HTR (Hard Tissue Replacement) Polymer Implants, Zimmer Biomet / Biomet…
  409. Urgent Field Safety Notice for Getinge 86-series by Getinge Disinfection AB
  410. Urgent Field Safety Notice for HeartMate 3, HeartMate 2 by Thoratec Corporation
  411. Urgent field safety notice for Warning Lamp Connectors & Chiller, Medtronic GmbH
  412. Urgent Field Safety Notice for Comprehensive Nano Humeral Component PPS by Biomet…
  413. Corrective action concerning the cleaning instructions for AMPLITUDE orthopedic surgical…
  414. Urgent Field Safety Notice for BVM (Bag-Valve-Mask) Manual Resuscitation Systems by…
  415. Safety Notice concerning the KleenSpec® Disposable Vaginal Specula, Welch Allyn Inc.
  416. Urgent Field Safety Notice for Philips SureSigns VS Monitors by Philips Medical Systems
  417. Recall for the ISKD, ORTHOFIX
  418. Corrective action for the cobas HbA1c Test on the cobas b101 System, Roche
  419. Safety notice for non-sterile alcohol prep pads manufactured by PDI in Spacelabs…
  420. Recall of intravenous line stopcock, B.Braun
  421. Safety Notice concerning malfunction of the Semikron Diode of all SL75/5 Linacs, Elekta
  422. Urgent Field Safety Notice for ALPS; DVR; Juggerloc; SnapShot by Biomet Orthopedics, LLC
  423. Urgent Field Safety Notice for ACDA Antikoagulanzlösung by Maco Pharma International GmbH
  424. Urgent Field Safety Notice for Diverse Dentalimplantate by VICTORY
  425. ARCHITECT Testosterone Calibrators
  426. Safety Information concerning all RT300 FES cycles with software versions 3.05.061 or…
  427. Urgent Field Safety Notice for FRED easyport plus by Schiller AG
  428. Urgent field safety notice for neoBLUE LED Phototherapy System, Natus Medical Incorporated
  429. Urgent Field Safety Notice for CAIMAN MARYLAND NON ARTICULAT.D5/360MM by Aesculap AG
  430. Urgent Field Safety Notice for Vasofix Safety, Vasofix Certo by B. Braun Melsungen AG
  431. Urgent Field Safety Notice for Optimizer III, Impulse Dynamics
  432. Urgent Field Safety Notice for Alere NT-proBNP Control/Alere NT-proBNP Calibrator by…
  433. Corrective action for the Allura Xper Systems (Monitor Ceiling Suspension), Philips…
  434. Anomaly identified with Eclipse Treatment Planning System, Varian medical systems
  435. Urgent Field Safety Notice for Volista by MAQUET SAS
  436. Urgent Field Safety Notice for IntelliSpace Cardiovascular ISCV by Philips Healthcare
  437. Corrective Action for Ketochrome 17-Ketosteroids by Column Test, Ketochrome…
  438. Urgent Field Safety Notice for PICO70 by Radiometer Medical ApS
  439. Lot Recall of the bone cement Palacos MV+G, HERAEUS
  440. Important Safety Notice for oxygenators, Sorin Group Italia
  441. Zimmer Trabecular Metal Reverse Glenosphere Distractor
  442. Urgent Field Safety Notice for Pentax Video Duodenoscope by HOYA Corp., Pentax Tokyo…
  443. Safety Notice: Software Update for Brilliance 64, Ingenuity CT and Brilliance Big Bore CT…
  444. Corrective action for the Valved Entry Systems sold as stand-alone, within CONSTELLATION®…
  445. Urgent Field Safety Notice for DxH 500 by Beckman Coulter Ireland Inc.
  446. Recall for VolumeView Set Thermodilution Cable Model EVVVTC1-Accessory to the EV1000…
  447. Lot Recall for the PRO-Kinetic coronary stent system, Biotronik
  448. Urgent Field Safety Notice for CRP IS / Super ID CRP; TruLab CRP / Nobicon CRP by DiaSys…
  449. Urgent Recall of the Vectra System graduated 2.5mm Drill Bit and the Adjustable Drill…
  450. Corrective action for Indiko, Indiko Plus, Gallery, Gallery Plus und Gallery Plus Beer…
  451. Urgent Recall of the CSLP System Ø 3.0mm Drill Bits and the Fixation Sleeve, Synthes GmbH
  452. Recall for the Pilling® Derra Anastomosis Clamp, Teleflex Medical
  453. Corrective action for the Supplementary Reagents for CFT (Sheep Blood), Siemens Healthcare…
  454. Corrective measure for AXIOM / Artis zee in conjunction with a wireless foot switch…
  455. Urgent Field Safety Notice for 3DKnee by Encore Medical, LP (dba DJO Surgical)
  456. Urgent Field Safety Notice for Atrium Advanta V12 Covered Stent by Atrium Medical…
  457. Urgent Safety Notice for the 550 TxT™ Treatment Table, SIEMENS Healthcare
  458. Corrective Action for Creatinin PAP FS / Creatinin FS, DiaSys
  459. Recall for VITROS Calibrator Kit 16, Ortho Clinical Diagnostics
  460. Urgent Safety Notice for the product Phorbas, Promedon
  461. Safety Notice for the Ingenuity TF PET/CT Software Version 4.0, Philips Healthcare
  462. Corrective action for the Trak Back II Catheter Pull-back System, Volcano Corporation
  463. Product issue related to the CO2 sampling lines, Oridion
  464. Urgent Field Safety Notice for Ysio systems with fixed detector in wall stand with…
  465. Safety Notice concerning a recall for several lots of SERFAS Energy Probes Super 90S…
  466. Updated Reprocessing Procedure for unsterile surgical needles and cannulas, Ernst Kratz…
  467. Corrective action for the AngioJet® Ultra Spiroflex® VG® Thrombectomy Set, Bayer…
  468. Recall of 3T 16ch Flex SPEEDER Large, NeoCoil LLC / Toshiba
  469. Urgent Field Safety Notice for RF IK II, RF IK II M coat, Glidesheath Slender by Terumo…
  470. Chargenrückruf für GENESIS Trocar Pin, Smith & Nephew Inc.
  471. Urgent Field Safety Notice for DxA Automation System / DxA Aliquoter by Beckman Coulter…
  472. Field Safety Notice concerning an issue with the dose volume statistics calculation in…
  473. Corrective action for chromID Salmonella Agar, bioMérieux
  474. Recall for the Armada 35 und Armada 35 LL PTA Catheters, Abbott Vascular
  475. Urgent Safety Notice for the paediatric endotracheal tube, Vygon
  476. Urgent Field Safety Notice for PrepPlus 2 and PrepPlus Sample Preparation Systems by…
  477. Field Safety Notice concerning AVEA ventilators, CareFusion
  478. Recall of cemented 11 mm MML Adapter Stems, Orthodynamics
  479. Urgent Field Safety Notice for Renuvion/J-Plasma Precise & Precise Open Handpiece by Apyx…
  480. Urgent Field Safety Notice for LeadCare/ LeadcareII/Leadcare Ultra/Leadcare Plus by…
  481. Pentra C400
  482. Urgent Field Safety Notice for IntelliCuff Standalone by Hamilton Medical AG
  483. Urgent Field Safety Notice for HL7-WorklistServer/Commander by getemed Medizin- und…
  484. Lot recall of Exeter Rasp Handle, Stryker Orthopaedics
  485. Urgent Field Safety Notice for 29mm Blue REGUS Circular Stapler RCS-29 by Regus Surgical…
  486. Safety Notice for the VitreaCore PET/CT feature of the Vitrea Enterprise Suite, Vital…
  487. Urgent Field Safety Notice for MEDUCORE Standard 2 by WEINMANN Emergency Medical…
  488. Amendment to the instructions for use of Sulcoflex intraocular lens, Rayner Intraocular…
  489. Urgent Field Safety Notice for GenomEra molecular analyzer, GenomEra CDX System by Abacus…
  490. Urgent Field Safety Notice for PERI-GUARD by Synovis Life Technologies, Inc. (a subsidiary…
  491. Urgent Field Safety Notice for BARRIER TUR Set by Mölnlycke Health Care AB
  492. Urgent Field Safety Notice for EVA NEXUS by D.O.R.C. Dutch Ophthalmic Research Center…
  493. Important Information for the Accu-Chek Insight system, Roche Diabetes Care
  494. Urgent Field Safety Notice for Zenith Alpha Abdominal Endovascular Graft - ZIMB ZLC ZLBE…
  495. Urgent Field Safety Notice for Artis Zee ceiling by Siemens Healthcare GmbH Advanced…
  496. Urgent Field Safety Notice for Zimmer Plates and Screws, Zimmer Universal Locking by…
  497. Arctic Sun Temperature Management System
  498. Corrective action for the CA 19-9 Test, Siemens Healthcare
  499. Ethicon Endo-Surgery, LLC (Ethicon): Recall for the PROXIMATE® RH Rotating Head Skin…
  500. Recall of Pediatric Arterial Cannula, Maquet
  501. Urgent Field Safety Notice for LI-11plus G, LI-12plus G, Micro-Access Tearaway In by Galt…
  502. Urgent Field Safety Notice for Heat exchanger and infusion s.t.- TEIDE 150 by CAIR LGL
  503. Corrective action for ACL AcuStar System Software, Instrumentation Laboratory
  504. Urgent Field Safety Notice for ADVIA Chemistry System by Siemens Healthcare Diagnostics…
  505. Recall of several Sharpoint Slit Knives, Surgical Specialties Puerto Rico dba Angiotech
  506. Safety Notice concerning a problem with Autoclave HMT 232X, Sturdy Industrial
  507. Urgent Field Safety Notice for HARMONIC ACE + Shears with Adaptive Tissue Technology (23CM…
  508. Recall for the ADVIA Centaur Prolactin Assay, Siemens
  509. Urgent Field Safety Notice for SPOTCHEM CALIBRATOR KIT by Arkray Factory, Inc.
  510. Urgent Field Safety Notice for VivaDiag SARS-CoV-2 Ag Rapid Test by VivaChek Biotech…
  511. Lot Recall for Rüsch Flexislip/Flexi-Slip Endotracheal Tube Stylet with Soft Distal Zip…
  512. Urgent Field Safety Notice for HeartStart Intrepid by Philips Goldway (Shenzhen)…
  513. Recall for Access Immunoassay Systems / Ostase Calibrator, -QC and Reagent Kits, Beckman…
  514. Corrective action for the Vapotherm Precision Flow Disposable Patient Circuit, Vapotherm…
  515. Safety Notice concerning the Minivator Bath Bliss bath lift 311, Handicare Ltd.
  516. Corrective action for Dimension Vista HCYS Flex reagent cartridge, Siemens
  517. Urgent field safety notice for Eye Care PACS and Eye Station, Merge Healthcare
  518. Lot recall of CELL-DYN Emerald Cleaner, Abbott
  519. Safety Notice for Argyle™ Single Lumen Polyurethane Umbilical Vessel Catheters, Covidien
  520. Urgent Safety Notice for the V5Ms transesophageal transducer, Siemens Medical Solutions…
  521. Urgent field safety notice for Eye Station and Eye Care PACS, Merge Healthcare
  522. Corrective action for Dimension Vista® HbA1c assay, Siemens Healthcare Diagnostics
  523. Urgent Field Safety Notice for HeartMate 3 LVAS Implant Kit, HeartMate 3 Pump by Thoratec…
  524. Corrective action for the CentraLink™ Data Management System, Siemens Healthcare…

About this dataset

Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.

Source: National medical device regulators (as listed), compiled by Orca1