FDA Device recall Z-2064-2020
HeartStart MRx Processor Board PCA Replacement Kits 453563478461, a component of the Philips HeartStart MRx Monitorl/Defibrillator - Produc…
- FDA Device
- Class II
- terminated
- Published 2020-05-27
On 2020-05-27 the FDA classified a Class II recall of HeartStart MRx Processor Board PCA Replacement Kits 453563478461, a component of the Philips HeartStart MRx Monitorl/Defibrillator - Produc… by Philips North America, citing damaged ESD bags used for storing components in Processor PCA Replacement Kits.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2064-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-04-10 |
| Published | 2020-05-27 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Philips North America |
| Distribution | US |
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 in basic life support, advanced cardiac life support or defibrillation.
Reason
Damaged ESD bags used for storing components in Processor PCA Replacement Kits
Identifiers
| code_info | Serial Numbers: CO1-1643IDOTDB CO1-1639100N3T C01-16391D0NB2, CO1-1639100N43 C01-1639100ND0 C01-16391D0N6N, C01-16391D0N4N C01-1&39IDON1J |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2064-2020%22
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