FDA-Device2020-03-04Class II
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.
Philips North America, LLC
Hazard
M4758A Ambulance Parameter Extension (APE) kit may cause ECG "Leads Off" condition in hot, humid environments
Sold states
International distribution in the countries of Austria, Germany, Netherlands, Norway, Poland, Switzerland
Affected count
43 units
Manufactured in
3000 Minuteman Rd, N/A, Andover, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1342-2020Don't want to check this manually?
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