Reported Mar 19, 2025 · Ongoing
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-00A, (2) G5A-01A, (3) G5A-02A, (4)…
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 Number
(1) G5A-00A(2) G5A-01A(3) G5A-02A(4) G5A-03A(5) G5A-19A(6) G5A-80A(7) G5A-80A-TSO
- 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 Number
(1) G5A-00A(2) G5A-01A(3) G5A-02A(4) G5A-03A(5) G5A-19A(6) G5A-80A(7) G5A-80A-TSO
- UDI-DI
(1) no UDI(2) 00812394021154(3) no UDI(4) no UDI(5) 00812394022243(6) 00812394021192(7) 00812394021390
- Serial Numbers
2,268 of 2,268 codes
(1) D00000177884D00000177917D00000177931D00000177956D00000178271D00000178311D00000178395D00000178542M00000002041M00000008225M00000008290M00000008336(2) D00000003482D00000003546D00000003557D00000003600D00000003625D00000003783D00000003978D00000003983D00000003985D00000004036D00000004037D00000004040D00000004043D00000004089D00000004098D00000004100D00000004105D00000004107D00000004109D00000004111D00000004116D00000004118D00000004119D00000004120D00000004123D00000004129D00000004131D00000004132D00000004133D00000004138D00000004140D00000004141D00000004142D00000004143D00000004145D00000004146D00000004147D00000004148D00000004150D00000004155D00000004157D00000004159D00000004160D00000004161D00000004162D00000004163D00000004164D00000004165
- Model/Catalog Number
- Amount recalled
- 2268 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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