# FDA recall Z-2324-2024

> **Zoll Medical Corporation** · Class II · device recall initiated 2024-05-31.

## Product

ZOLL Powerheart G5 AED, Semi-Automatic, G5Sxxx Family -Automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ventricular fibrillation, that cause Sudden Cardiac Arrest (SCA).     Model/Catalog Number:    G5S-00A  G5S-00A-TSO  G5S-00C  G5S-01A  G5S-02A  G5S-02C  G5S-02-L  G5S-04A  G5S-05A  G5S-05C  G5S-06A  G5S-06C  G5S-08A  G5S-08C  G5S-10A  G5S-10C  G5S-11A  G5S-11C  G5S-12C  G5S-13A  G5S-14A  G5S-15A  G5S-17A  G5S-17C  G5S-19A  G5S-23C  G5S-29A  G5S-29C  G5S-31A  G5S-31A-SJA  G5S-31C-SJA  G5S-36A  G5S-37A  G5S-41A  G5S-41C  G5S-80A  G5S-80A-TSO  G5S-80C  G5S-80-L  G5S-82A  G5S-82C  G5S-83C  G5S-90C

## Reason for recall

G5 Semi-Automatic AED is shipped, with a protective film over its front panel, to protect the screen and  shock button from cosmetic damage during shipping. It has come to our attention that customers may not be removing the protective film during deployment of the product. If the protective film is left adhered to the front bezel it may prevent the user from actuating the shock button and may lead to a delay or prevent delivery of defibrillation therapy to a victim suffering from sudden cardiac arrest

## Distribution

Nationwide including PR. Foreign: AU BM CA CH DE DK ES FR GB HK HU ID IE IL IT KR MA MT NL NO PR SA SE SI SN TR

## Key facts

- **Recall number:** Z-2324-2024
- **Recalling firm:** Zoll Medical Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-05-31
- **Report date:** 2024-07-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Deerfield, WI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2324-2024

## Citation

> AI Analytics. FDA recall Z-2324-2024. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-2324-2024. Source: US FDA. Licensed CC0.

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