Reported Mar 19, 2025 · Ongoing
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-80C, (2) G5A-80C-TSO. Software Version:…
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-80C(2) G5A-80C-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-80C(2) G5A-80C-TSO
- UDI-DI
(1) 00812394021208(2) 00812394021406
- Serial Numbers
2,320 of 2,320 codes
(1) D00000022708D00000033165D00000033168D00000033171D00000033174D00000033185D00000033187D00000033189D00000033191D00000033208D00000033209D00000033211D00000033213D00000033214D00000033216D00000033217D00000033219D00000033220D00000033221D00000033222D00000033230D00000035201D00000035208D00000035246D00000035445D00000035512D00000035517D00000035521D00000035523D00000035524D00000035525D00000035528D00000035530D00000035532D00000035534D00000035536D00000035538D00000035539D00000035542D00000035544D00000035546D00000035548D00000035549D00000035554D00000035558D00000035560D00000035562D00000035584D00000035585D00000035588D00000035589D00000035591D00000035594D00000035595D00000035599D00000035601D00000035603D00000035605D00000035607D00000035610
- Model/Catalog Number
- Amount recalled
- 63,607 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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