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.
This recall has been terminated (originally issued January 14, 2020).
- Company
- Philips North America, Llc
- Recall Initiated
- January 14, 2020
- Terminated
- February 9, 2021
- Recall Number
- Z-1342-2020
- Quantity
- 43 units
- Firm Location
- Andover, MA
- Official Source
- View on FDA website ↗
Reason for Recall
M4758A Ambulance Parameter Extension (APE) kit may cause ECG "Leads Off" condition in hot, humid environments
Distribution
International distribution in the countries of Austria, Germany, Netherlands, Norway, Poland, Switzerland
Lot / Code Info
All
Root Cause
Process design
Action Taken
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 convenience.