# FDA recall Z-2794-2020

> **Philips North  America, LLC** · Class II · device recall initiated 2020-07-16.

## Product

Philips HeartStart MRx, Monitor/Defibrillators with model numbers M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9 - Product Usage:  is intended for use in hospital and pre-hospital settings by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac life support or defibrillation.

## Reason for recall

The therapy switch may fail, resulting in the device exhibiting the following behaviors: the device may not perform the selected function, the therapy knob may not change to the energy setting selected, or the device may deliver a shock with an energy level different from the setting selected by the user. These device behaviors could result in a delay in therapy or a failure to deliver the intended therapy.

## Distribution

Worldwide distribution.

## Key facts

- **Recall number:** Z-2794-2020
- **Recalling firm:** Philips North  America, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-07-16
- **Report date:** 2020-08-19
- **Termination date:** 2021-08-03

- **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-2794-2020

## Citation

> AI Analytics. FDA recall Z-2794-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2794-2020. Source: US FDA. Licensed CC0.

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