Home / Recalls / Philips Electronics North America Corporation / Z-2035-2018

Z-2035-2018 Class II Terminated

Recalled by Philips Electronics North America Corporation — Andover, MA

Recall Details

Product Type
Devices
Report Date
June 6, 2018
Initiation Date
May 3, 2018
Termination Date
October 17, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5

Product Description

HeartStart MRx Monitor/Defibrillator, Model No. M3535A (861288), M3536A (861289) Product Automated external defibrillators (non-wearable) Product Usage: The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.

Reason for Recall

The MRx monitor/defibrillators could fail to charge because the therapy printed circuit board may have been loaded with an incorrect electronic component. Failure to charge could potentially cause therapy to be interrupted or delayed.

Distribution Pattern

Worldwide Distribution to accounts in OH and NC. Foreign distribution to Lebanon.

Code Information

US00588464, US00588657, US00589878, US00591080, US00593861

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  • Z-3213-2018 Class II — INTEGRIS Allura 9, System Code 722018 Vascular, cardiovascular and neurovasc (July 16, 2018)
  • Z-3236-2018 Class II — Allura Xper F020 Biplane DR Table, System Code 722020 Vascular, cardiovascul (July 16, 2018)
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