Device recall
Z-1148-2007: biphasic LIFEPAK 500 automated external defibrillators (AEDs) with software…
FDA device recall · Class II · Medtronic Emergency Response Systems, Inc.
Key facts
| Recall number (Z-number) | Z-1148-2007 |
|---|---|
| Recall event | 38232 |
| Product | biphasic LIFEPAK 500 automated external defibrillators (AEDs) with software version 4.4 or lower; Part Nos. 3011790-XXXXXX, D3100790-XXXXXX, and U3011790-XXXXXX . (XXXX indicates various non-contiguous numbers) |
| Product code | MKT |
| Recalling firm | Medtronic Emergency Response Systems, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 20, 2011 |
| 510(k) numbers | K955854 |
| FEI number | 3015876 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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