Device recall
Z-3231-2017: Platinium VR DF4 1240, Model Number TDF035U, UDI/GTIN 08031527015460…
FDA device recall · Class II · Sorin Group Italia SRL - CRF
Key facts
| Recall number (Z-number) | Z-3231-2017 |
|---|---|
| Recall event | 77983 |
| Product | Platinium VR DF4 1240, Model Number TDF035U, UDI/GTIN 08031527015460, Implantable cardioverter defibrillator, Biventricular or ventricular antitachycardia pacing, Dual or single chamber arrhythmia detection Product Usage: PLATINIUM VR is indicated for use in patients who are at high risk of sudden… |
| Product code | MRM |
| Recalling firm | Sorin Group Italia SRL - CRF |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 29, 2024 |
| PMA numbers | P980049 |
| FEI number | 1000165971 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database