# FDA recall Z-2488-2019

> **Philips North  America, LLC** · Class II · device recall initiated 2019-07-16.

## Product

HeartStart MRx Monitor/Defibrillator  Model # M3535A - Product Usage: The HeartStart MRx is a lightweight, portable external defibrillator, offering two modes of operation for defibrillation: manual mode and semi-automatic mode (AED). In manual mode, the HeartStart MRx is a full featured manual defibrillator, designed for use by clinicians trained in Advanced Cardiac Life Support (ACLS). Manual operation allows users to select energy levels for external and internal defibrillation. Users may also perform synchronized cardioversion. Non-invasive external pacing is a device option. In AED mode, the HeartStart MRx allows the provider who is trained in Basic Life Support (BLS) to provide defibrillation therapy. The device analyzes a patient s rhythm and advises the user to deliver a shock. Voice prompts guide the user through the defibrillation process by providing instructions and patient information. The voice prompts are reinforced by messages that appear on the display. In both modes o

## Reason for recall

Non-conforming devices are identified, which may not have been included in prior field actions and may not have had a number of corrections applicable to these devices.

## Distribution

US Nationwide distribution in the state of MA.

## Key facts

- **Recall number:** Z-2488-2019
- **Recalling firm:** Philips North  America, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-07-16
- **Report date:** 2019-09-18
- **Termination date:** 2022-10-20

- **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-2488-2019

## Citation

> AI Analytics. FDA recall Z-2488-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2488-2019. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*