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.
Reported: March 4, 2020 Initiated: January 14, 2020 #Z-1342-2020
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
Details
- Recalling Firm
- Philips North America, LLC
- Units Affected
- 43 units
- Distribution
- International distribution in the countries of Austria, Germany, Netherlands, Norway, Poland, Switzerland
- Location
- Andover, MA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Philips North America, LLC. Units affected: 43 units.
Why was this product recalled? ▼
M4758A Ambulance Parameter Extension (APE) kit may cause ECG "Leads Off" condition in hot, humid environments
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 4, 2020. Severity: Moderate. Recall number: Z-1342-2020.
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