Z-1342-2020 Class II Terminated
FDA device recall Z-1342-2020 was initiated by Philips North America, LLC on January 14, 2020 and is designated Class II. Reason for recall: M4758A Ambulance Parameter Extension (APE) kit may cause ECG "Leads Off" condition in hot, humid environments The recall status is terminated (terminated February 9, 2021). Affected quantity: 43 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 4, 2020
- Initiation Date
- January 14, 2020
- Termination Date
- February 9, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 43 units
Product Description
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.
Reason for Recall
M4758A Ambulance Parameter Extension (APE) kit may cause ECG "Leads Off" condition in hot, humid environments
Distribution Pattern
International distribution in the countries of Austria, Germany, Netherlands, Norway, Poland, Switzerland
Code Information
All