Device recall
Z-1225-2014: Philips HeartStart FR3 Automated External Defibrillator (AED), models 861388 and…
FDA device recall · Class II · Philips Medical Systems North America Inc.
Key facts
| Recall number (Z-number) | Z-1225-2014 |
|---|---|
| Recall event | 67622 |
| Product | Philips HeartStart FR3 Automated External Defibrillator (AED), models 861388 and 861389. The HeartStart FR3 is a battery powered automated external defibrillator (AED) designed for use by responders who have been trained in Basic Life Support (BLS), Advanced Life Support (ALS), or another… |
| Product code | MKJ |
| Recalling firm | Philips Medical Systems North America Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 29, 2017 |
| 510(k) numbers | K111693 |
| 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