Device recall
Z-0816-03: Belos VR - implantable cardioverter defibrillator. Implantable Cardioverter…
FDA device recall · Class II · Biotronik Inc
Key facts
| Recall number (Z-number) | Z-0816-03 |
|---|---|
| Recall event | 26041 |
| Product | Belos VR - implantable cardioverter defibrillator. Implantable Cardioverter Defibrillators. The Belos VR is a single-chamber implantable cardioverter defibrillator (ICD) that detects and treats ventricular tachyarrhythmias and provides rate adaptive bradycardia pacing support. The ICDs are designed… |
| Product code | LWS |
| Recalling firm | Biotronik Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 13, 2004 |
| PMA numbers | P980023, P980023/S4 |
| FEI number | 1028232 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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