Reported Mar 19, 2025 · Ongoing
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-80C; 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-80C
- 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-80C
- UDI-DI00812394021284
- Serial Numbers
2,324 of 2,324 codes
D00000171086D00000171087D00000171088D00000171089D00000171090D00000171092D00000171093D00000171094D00000171095D00000171096D00000171097D00000171098D00000171099D00000171100D00000171101D00000171102D00000171103D00000171105D00000171107D00000171109D00000171111D00000171113D00000171115D00000171117D00000171118D00000171121D00000171126D00000171133D00000171134D00000171136D00000171138D00000171140D00000171144D00000171147D00000171150D00000171154D00000171157D00000171159D00000171160D00000171164D00000171165D00000171166D00000171167D00000171168D00000171169D00000171170D00000171171D00000171172D00000171178D00000171179D00000171181D00000171183D00000171186D00000171188D00000171190D00000171601D00000172373D00000172376D00000172379D00000172381
- Amount recalled
- 7,221 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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