# FDA recall Z-2035-2018

> **Philips Electronics North  America Corporation** · Class II · device recall initiated 2018-05-03.

## Product

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

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

## Key facts

- **Recall number:** Z-2035-2018
- **Recalling firm:** Philips Electronics North  America Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-05-03
- **Report date:** 2018-06-06
- **Termination date:** 2019-10-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Andover, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2035-2018

## Citation

> AI Analytics. FDA recall Z-2035-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2035-2018. Source: US FDA. Licensed CC0.

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