Recall Z-2064-2020 ยท MKJ Automated External Defibrillators (Non-Wearable)
Philips North America, LLC
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.
| Date | Apr 10, 2020 |
| Status | Terminated |
| Reason | Damaged ESD bags used for storing components in Processor PCA Replacement Kits |
| Root cause | Process control |
| Action | Philips Healthcare ssued Medical Device Correction letter dated April 10, 2020 via USP stating reason for correction, health risk and action to take: If the Processor Board PCA Replacement Kit has not yet been installed in a Heart5tart MRx Monitor/Defibrillator, quarantine the kit until Philips can replace it. If the PCA has been installed in a HeartStart MRx Monitor/Defibrillator, continue to monitor the status of the device as recommended in the Instructions for Use, including performing Operational Checks routinely as recommended in the Instructions for Use. Verify your MRx does not show a |
| Quantity | 8 units (2 US and 6 OUS) |
| Distribution | Worldwide distribution - US Nationwide distribution including in the states of OK, NY and the countries of Libya, Netherlands, Canada, South Africa, United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063375 | HEARTSTART MRX, MODELS M3535A OR M3536A Philips Medical Systems, Jan 11, 2007 |