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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Ambulance Parameter Extension Kit

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 Class 2 Device Recall Philips Ambulance Parameter Extension Kitsee related information
Date Initiated by FirmJanuary 14, 2020
Create DateFebruary 21, 2020
Recall Status1 Terminated 3 on February 09, 2021
Recall NumberZ-1342-2020
Recall Event ID 84796
510(K)NumberK063375 
Product Classification Automated external defibrillators (non-wearable) - Product Code MKJ
ProductAmbulance 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.
Code Information All
FEI Number 1218950
Recalling Firm/
Manufacturer		 Philips North America, LLC
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information ContactPhilips Customer Services
800-722-9377
Manufacturer Reason
for Recall		M4758A Ambulance Parameter Extension (APE) kit may cause ECG "Leads Off" condition in hot, humid environments
FDA Determined
Cause 2		Process design
ActionPhilips 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.
Quantity in Commerce43 units
DistributionInternational distribution in the countries of Austria, Germany, Netherlands, Norway, Poland, Switzerland
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = MKJ
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