Device recall
Z-0489-2018: MRx Defibrillator Model # M3535A & M3536A, UDI 00884838000018(21)US00601969…
FDA device recall · Class I · Philips North America, LLC
Key facts
| Recall number (Z-number) | Z-0489-2018 |
|---|---|
| Recall event | 78351 |
| Product | MRx Defibrillator Model # M3535A & M3536A, UDI 00884838000018(21)US00601969 Product Usage: The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and… |
| Product code | MKJ |
| Recalling firm | Philips North America, LLC |
| Recall class | Class I |
| Status | Terminated |
| Termination date | May 27, 2020 |
| 510(k) numbers | K031187, K040404, K051134, K061707, K062233 |
| 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