Device recall
Z-2157-2020: Philips HeartStart MRx Monitor/Defibrillators Model numbers M3535A, M3536A, and…
FDA device recall · Class II · Philips North America, LLC
Key facts
| Recall number (Z-number) | Z-2157-2020 |
|---|---|
| Recall event | 85588 |
| Product | Philips HeartStart MRx Monitor/Defibrillators Model numbers M3535A, M3536A, and M3536M - Product Usage: is for use for the termination of ventricular tachycardia and ventricular fibrillation. |
| Product code | MKJ |
| Recalling firm | Philips North America, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 19, 2021 |
| 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