Sorin Group Italia SRL - CRF
FDA Regulatory Profile
Summary
- Total Recalls
- 9
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-3228-2017 | Class II | Platinium VR 1210, Model Number TDF031U, UDI/GTIN 08031527015514, Implantable cardioverter defibrill | July 24, 2017 |
| Z-3233-2017 | Class II | Platinium CRT-D 1741, Model Number TDF037U, UDI/GTIN 08031527015484, Implantable cardioverter defibr | July 24, 2017 |
| Z-3229-2017 | Class II | Platinium DR 1510, Model Number TDF032U, UDI/GTIN 08031527015521, Implantable cardioverter defibrill | July 24, 2017 |
| Z-3232-2017 | Class II | Platinium DR DF4 1540, Model Number TDF036U, UDI/GTIN 08031527015477, Implantable cardioverter defib | July 24, 2017 |
| Z-3231-2017 | Class II | Platinium VR DF4 1240, Model Number TDF035U, UDI/GTIN 08031527015460, Implantable cardioverter defib | July 24, 2017 |
| Z-3230-2017 | Class II | Platinium CRT DF1 1711, Model Number TDF033U, UDI/GTIN 08031527015538, Implantable cardioverter defi | July 24, 2017 |
| Z-2114-2017 | Class II | INTENSIA Models: VR 124, DR 154, CRT-D 174 Product Usage: OVATIO VR 6250, OVATIO DR 6550, PARAD | April 11, 2017 |
| Z-2112-2017 | Class II | OVATIO Models: VR 6250, DR 6550, CRT 6750. Product Usage: OVATIO VR 6250, OVATIO DR 6550, PARA | April 11, 2017 |
| Z-2113-2017 | Class II | PARADYM Models: VR 8250, DR 8550, CRT-D 8750, RF VR 9250, RF DR 9550, RF CRT-D 9750, SonR 8770, RF | April 11, 2017 |