Recall Z-1342-2020 ยท MKJ Automated External Defibrillators (Non-Wearable)
Philips North America, LLC
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.
| Date | Jan 14, 2020 |
| Status | Terminated |
| Reason | M4758A Ambulance Parameter Extension (APE) kit may cause ECG "Leads Off" condition in hot, humid environments |
| Root cause | Process design |
| Action | Philips issued notification letter dated January 2020 to Philips Markets Organizations responsible for distributing the letters outside of the U.S Letter stated problem, health risk and is asking customers to follow the Action to be Taken by Customer/User section of the CIL: Philips recommends that the APE kit be removed from use and disposed of. Patients can of course be monitored and treated in ambulances using the MRx Monitor/Defibrillator without the APE kit. To acknowledge receipt of this notification, please complete and fax the Customer Reply Form back to Philips at your earliest con |
| Quantity | 43 units |
| Distribution | International distribution in the countries of Austria, Germany, Netherlands, Norway, Poland, Switzerland |
| 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 |