Reported Mar 19, 2025 · Ongoing
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5S-00A-TSO, (2) G5S-01A, (3) G5S-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) G5S-00A-TSO(2) G5S-01A(3) G5S-02A(4) G5S-05A(5) G5S-08A(6) G5S-10A(7) G5S-11A(8) G5S-80A-TSO(9) G5S-80-L (10) G5S-90A
- 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) G5S-00A-TSO(2) G5S-01A(3) G5S-02A(4) G5S-05A(5) G5S-08A(6) G5S-10A(7) G5S-11A(8) G5S-80A-TSO(9)G5S-80-L(10) G5S-90A
- UDI-DI
(1) no UDI(2) 00812394021239(3) no UDI(4) no UDI(5) no UDI(6) no UDI(7) no UDI(8) 00812394021413(9) no UDI(10) no UDI
- Serial Numbers
1,312 of 1,312 codes
(1) D00000154575D00000154617(2) D00000003725D00000003727D00000003734D00000003896D00000003898D00000003923D00000003927D00000003941D00000003943D00000003951D00000003955D00000003962D00000003964D00000003965D00000003968D00000003971D00000003972D00000003981D00000003982D00000003984D00000003987D00000003989D00000003991D00000003997D00000003999D00000004149D00000004151D00000004153D00000004154D00000004156D00000004158D00000004301D00000004304D00000004308D00000004313D00000004324D00000004329D00000004365D00000004390D00000004394D00000004402D00000004407D00000004408D00000004410D00000004413D00000004427D00000004441D00000004464D00000004509D00000004515D00000004516D00000004654D00000004658D00000004659D00000004669D00000004672D00000004673D00000004698
- Model/Catalog Number
- Amount recalled
- 1312 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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