Device recall
Z-0062-2010: Heartstart FR2+ automated external defibrillator models M3861A and M3841A are…
FDA device recall · Class II · Philips Medical Systems
Key facts
| Recall number (Z-number) | Z-0062-2010 |
|---|---|
| Recall event | 53383 |
| Product | Heartstart FR2+ automated external defibrillator models M3861A and M3841A are NOT equipped with the ECG Module. Model M3861A is under the Philips label and M3841A is under the Laerdal label. |
| Product code | MKJ |
| Recalling firm | Philips Medical Systems |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 27, 2013 |
| 510(k) numbers | K051632 |
| FEI number | 1000524572 |
At a glance
- 1–9 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