Device recall
Z-1189-2013: HeartStart MRx Monitor/Defribillator; Product Codes: M3536A, M3536J, M3536M…
FDA device recall · Class II · Philips Healthcare Inc.
Key facts
| Recall number (Z-number) | Z-1189-2013 |
|---|---|
| Recall event | 64860 |
| Product | HeartStart MRx Monitor/Defribillator; Product Codes: M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6. The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. |
| Product code | MKJ |
| Recalling firm | Philips Healthcare Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 10, 2017 |
| 510(k) numbers | K051134 |
| FEI number | 1218950 |
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