Device recall
Z-1342-2020: Ambulance Parameter Extension (APE) kit M4758A, an accessory to the Philips…
FDA device recall · Class II · Philips North America, LLC
Key facts
| Recall number (Z-number) | Z-1342-2020 |
|---|---|
| Recall event | 84796 |
| Product | Ambulance Parameter Extension (APE) kit M4758A, an accessory to the Philips HeartStart MRx Monitor/Defibrillator - Product Usage: is intended to be used with the M3536A MRx in EMS environments. |
| Product code | MKJ |
| Recalling firm | Philips North America, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 9, 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