—#179421

Product

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.

FDA product code: MKJ — Automated External Defibrillators (Non-Wearable)
Device class: Class 3
Medical specialty: Cardiovascular
510(k) numbers: K063375
Affected lot / code info: All

Why it was recalled

M4758A Ambulance Parameter Extension (APE) kit may cause ECG "Leads Off" condition in hot, humid environments

Root cause (FDA determination)

Process design

Action the firm took

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.

Recalling firm

Firm: Philips North America, LLC
Address: 3000 Minuteman Rd, Andover, Massachusetts 01810-1032

Distribution

Distribution pattern: International distribution in the countries of Austria, Germany, Netherlands, Norway, Poland, Switzerland

Timeline

Recall initiated: 2020-01-14
Terminated: 2021-02-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #179421. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.