# FDA recall Z-2157-2020

> **Philips North  America, LLC** · Class II · device recall initiated 2020-04-27.

## Product

Philips HeartStart MRx Monitor/Defibrillators   Model numbers M3535A, M3536A, and M3536M - Product Usage: is for use for the termination of ventricular tachycardia and ventricular fibrillation.

## Reason for recall

HeartStart XL MonitorlDefibrillators may not have been included in prior field actions and received required corrections

## Distribution

Worldwide distribution - US Nationwide distribution and the countries of China, Republic of Korea, Netherlands, Norway, United Kingdom.

## Key facts

- **Recall number:** Z-2157-2020
- **Recalling firm:** Philips North  America, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-04-27
- **Report date:** 2020-06-03
- **Termination date:** 2021-07-19

- **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-2157-2020

## Citation

> AI Analytics. FDA recall Z-2157-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2157-2020. Source: US FDA. Licensed CC0.

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