Zoll Medical Corporation: Device Recall

Recall #Z-2324-2024 · 05/31/2024

Class II: Risk

Recall Details

Recall Number: Z-2324-2024
Classification: Class II
Product Type: Device
Recalling Firm: Zoll Medical Corporation
Status: Ongoing
Date Initiated: 05/31/2024
Location: Deerfield, WI, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 14885

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

Product Description

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

Distribution Pattern

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

Other Recalls by Zoll Medical Corporation

Class II: Risk 02/13/2025

The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
Class II: Risk 02/13/2025

The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
Class II: Risk 02/13/2025

The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
Class II: Risk 02/13/2025

The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
Class II: Risk 02/13/2025

The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).

View all recalls by Zoll Medical Corporation →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.