Reported Mar 19, 2025 · Ongoing
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-80A; Software Version: NA Product…
ZOLL Medical Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ZOLL Medical Corporation · 269 Mill Rd · Chelmsford, MA · 01824-4105
Is this the product you have?
- Brand NameZOLL
- Product NamePowerheart
- G5 AED Model/Catalog NumberG5S-80A
- Software VersionNA
- Product DescriptionThe Powerheart G5 automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ventricular fibrillation, that cause Sudden Cardiac Arrest (SCA). There are two models available fully automatic and semi-automatic. After the defibrillations pads are applied to the patient, the fully automatic model evaluates the heart rhythm and, if a shockable rhythm is detected, delivers a shock without any rescuer assistance. The semi-automatic model evaluates the heart rhythm and requires the rescuer to press the shock button if a shockable rhythm is detected. Both models have voice and text instructions that guide the rescuer through the entire defibrillation process
- NoteNot all configurations described in this document are available in all areas
- Lot codes and dates
- Model/Catalog NumberG5S-80A
- UDI-DI00812394021277
- Serial Numbers
2,324 of 2,324 codes
D00000003974D00000004048D00000004128D00000004404D00000004436D00000004556D00000004560D00000004563D00000004564D00000004573D00000004581D00000004582D00000004642D00000004665D00000004666D00000004718D00000004730D00000004736D00000004743D00000004744D00000004750D00000004770D00000004774D00000004779D00000004780D00000004784D00000004785D00000004787D00000004789D00000004794D00000004799D00000004800D00000004801D00000004802D00000004805D00000004806D00000004807D00000004808D00000004809D00000004810D00000004812D00000004815D00000004816D00000004818D00000004820D00000004821D00000004824D00000004873D00000004916D00000004929D00000004933D00000004939D00000004940D00000004951D00000004955D00000004960D00000004970D00000004974D00000004976D00000004983
- Amount recalled
- 8,744 units
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
Why it was recalled
The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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