Device recall
Z-2064-2020: HeartStart MRx Processor Board PCA Replacement Kits 453563478461, a component of…
FDA device recall · Class II · Philips North America, LLC
Key facts
| Recall number (Z-number) | Z-2064-2020 |
|---|---|
| Recall event | 85462 |
| Product | HeartStart MRx Processor Board PCA Replacement Kits 453563478461, a component of the Philips HeartStart MRx Monitorl/Defibrillator - Product Usage: is intended for use in hospital and prehospital settings by qualified medical personnel trained in the operation of the device and qualified by training… |
| Product code | MKJ |
| Recalling firm | Philips North America, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 10, 2021 |
| 510(k) numbers | K063375 |
| 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