# FDA recall Z-1931-2019

> **ZOLL Medical Corporation** · Class II · device recall initiated 2019-06-12.

## Product

ZOLL AED PRO Automated External Defibrillator    Product Usage:  The AED PRO unit is intended to defibrillate victims of ventricular fibrillation or pulseless ventricular tachycardia, for ECG monitoring, and for CPR monitoring of patients. The CPR monitoring function provides a metronome designed to encourage rescuers to perform chest compressions at the AHA/ERC recommended rate of 100 compressions per minute. Voice and visual prompts encourage a compression depth of at least 2 inches (5 cm) for adult patients. The AED PRO system is indicated for use on victims of cardiac arrest with apparent lack of circulation as indicated by:   Unconsciousness   Absence of breathing, and   Absence of pulse and other signs of circulation. The device is also indicated for use when ECG monitoring is indicated to evaluate the patient s heart rate or ECG morphology. The AED PRO system is indicated for adult and pediatric patients.

## Reason for recall

There is a potential for the device to fail to deliver energy to the patient.

## Distribution

Worldwide Distribution - US nationwide.    The products were distributed to the following foreign countries:  Austria, Australia, Bangladesh, Brazil, Canada, China, Denmark, France, Germany, Great Britain, Indonesia, Italy, Japan, Luxemburg, New Zealand, Panama, Russia, Saudi Arabia, Singapore, Spain, Thailand, Taiwan.

## Key facts

- **Recall number:** Z-1931-2019
- **Recalling firm:** ZOLL Medical Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2019-06-12
- **Report date:** 2019-07-10

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1931-2019

## Citation

> AI Analytics. FDA recall Z-1931-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1931-2019. Source: US FDA. Licensed CC0.

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