International safety notice
Alert 2527 (Technosurveillance) - Philips - Gyroscan ACS NT;
Brazil / Anvisa · BRA · Mar 21, 2018
Key facts
| Title | Alert 2527 (Technosurveillance) - Philips - Gyroscan ACS NT; |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Nome Comercial: Gyroscan ACS NT Technical Name: Magnetic Resonance Equipment Model: N/A Registration/Registration: 10216710012 Risk Class: II Nome Comercial: Gyroscant 10 NT Technical Name: Magnetic Resonance Equipment Model: N/A Registration/Registration: 10216710015 Risk Class: II Nome Comercial: Gyroscan T5 NT Technical Name: Magnetic Resonance Equipment Model: N/A Registration/Registration: 10216710020 Risk Class: II Commercial Name: Magnetic Resonance Equipment - INTERA Technical Name: Magnetic Resonance Equipment Model: Intera 1.0T; Registration/Registration: 10216710194 Risk Class: II Trade Name: Achieva Technical Name: Magnetic Resonance Equipment Model: Achieva 1.5T, Achieva 3.0T and Achieva XR Registration/Registration: 10216710205 Risk Class: II Trade Name: Ingenia Technical Name: Magnetic Resonance Equipment Model: Ingenia 1.5T / Ingenia 3.0T / Ingenia 1.5 T CX / Ingenia 3.0 T CX / Ingenia S 1.5T Registration/Registration: 10216710217 Risk Class: II Trade Name: Magnetic Resonance Equipment Technical Name: Magnetic Resonance Equipment Model: Multiva 1.5T Registration/Registration: 10216710293 Risk Class: II Lot number: See attached list |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO PHILIPS MEDICAL SYSTEMS LTDA CNPJ 58295213000178 AV TAMBORÉ 14001440 BOX 31 A 33 TAMBORÉ BARUERI SP FABRICANTE PHILIPS MEDICAL SYSTEMS NEDERLAND BV VEENPLUIS 46 5584 PC BEST HOLANDA EMAIL REGULATORIOSPHILIPSCOM |
| Models | 10216710012, 10216710217, 10216710205, 10216710293, 10216710020, 10216710015, 10216710194 |
| Date | Mar 21, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
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