International safety notice
Alert 2613 (Technovigilance) - Philips Medical Systems Ltda - Allura Xper Angiography Equipment Brand Philips / Allura Centron Possibility of incorrect redefinition of the collimator position additional exposure to radiation.
Brazil / Anvisa · BRA · Jul 12, 2018
Key facts
| Title | Alert 2613 (Technovigilance) - Philips Medical Systems Ltda - Allura Xper Angiography Equipment Brand Philips / Allura Centron Possibility of incorrect redefinition of the collimator position additional exposure to radiation. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial Name: Allura Xper Angiography Equipment Brand Philips / Allura Centron Technical Name: Angiography Equipment / Hemodynamics and Angiography Equipment ANVISA registration number: 10216710153 / 10216710299 Risk Class: III Model affected: Allura FD10; Affected serial numbers: 947; |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO PHILIPS MEDICAL SYSTEMS LTDA CNPJ 58295213000178 AV TAMBORÉ 14001440 BOX 31 A 33 TAMBORÉ BARUERI SÃO PAULO TEL 11 969109045 EMAIL LAISVIVONAPHILIPSCOM FABRICANTE DO PRODUTO PHILIPS MEDICAL SYSTEMS NEDERLAND BV PHILIPS INDIA LIMITED VEENPLUIS 46 5684 PC BEST PLOT NO B79 MIDC PHASEII CHAKAN TALUKA KHED VILLAGE SAVARDARI DISTRICT PUNE MAHARASHTRA 410 501 HOLANDA INDIA |
| Models | 10216710153, 10216710299 |
| Date | Jul 12, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
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