# FDA recall Z-1923-2019

> **Philips North  America, LLC** · Class II · device recall initiated 2019-06-07.

## Product

Philips HeartStart MRx devices in use with the M3539A AC Power Module:  M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9

## Reason for recall

The AC power module may fail at a higher than expected rate.  If a fully charged battery is not properly installed, the HeartStart MRx may lose all power and fail to operate.  Interruption of monitoring and failure or delay in the delivery of a shock or pacing can occur. A faulty AC Power Module may also fail to charge the battery.

## Distribution

Nationwide domestic distribution. Worldwide distribution.

## Key facts

- **Recall number:** Z-1923-2019
- **Recalling firm:** Philips North  America, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-06-07
- **Report date:** 2019-07-17
- **Termination date:** 2020-05-08

- **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-1923-2019

## Citation

> AI Analytics. FDA recall Z-1923-2019. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/Z-1923-2019. Source: US FDA. Licensed CC0.

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