Device recall
Z-1373-2008: Lumax Cardiac Resyncronization Therapy Defibrillator (CRT-D); Implantable…
FDA device recall · Class III · Biotronik Inc
Key facts
| Recall number (Z-number) | Z-1373-2008 |
|---|---|
| Recall event | 46751 |
| Product | Lumax Cardiac Resyncronization Therapy Defibrillator (CRT-D); Implantable, dual-chamber defibrillator; Model Number: HF-T; Catalog Number 355263; Software Version 603.U; Catalog Model Number 359251; ICS 3000 units are composed of three Catalog/Model Numbers: 349527, 349530, and 355547. The model… |
| Product code | MRM |
| Recalling firm | Biotronik Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | May 5, 2011 |
| PMA numbers | P050023, P050023S001, P050023S006 |
| FEI number | 1028232 |
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