Reported Mar 19, 2025 · Ongoing
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-01C, (2) G5A-02C, (3) G5A-05C, (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-01C(2) G5A-02C(3) G5A-05C(4) G5A-08C(5) G5A-10C(6) G5A-13C(7) G5A-15C(8) G5A-22C(9) G5A-41C(10) G5A-85C(11) G5A-90C (12) G5A-80-L
- 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-01C(2) G5A-02C(3) G5A-05C(4) G5A-08C(5) G5A-10C(6) G5A-13C(7) G5A-15C(8) G5A-22C(9) G5A-41C(10) G5A-85C(11) G5A-90C (12) G5A-80-L
- UDI-DI
(1) 00812394021161(2) no UDI(3) no UDI(4) no UDI(5) no UDI(6) no UDI(7) no UDI(8) no UDI(9) no UDI(10) 00812394021208 (11) no UDI(12) 00812394021215
- Serial Numbers
960 of 960 codes
(1) D00000066618D00000066630D00000066659D00000066773D00000067078D00000067079D00000067081D00000067082D00000067086D00000067088D00000067092D00000067094D00000067097D00000067099D00000067100D00000067103D00000067108D00000067109D00000067114D00000067117D00000067129D00000067133D00000067135D00000067136D00000067138D00000067139D00000067143D00000067145D00000067171D00000067172D00000067174D00000067178D00000067180D00000067183D00000067184D00000067186D00000067192D00000067195D00000067197D00000067199D00000067204D00000067209D00000067212D00000067217D00000067219D00000067224D00000067233D00000067235D00000067267D00000067303D00000067384D00000067456D00000067577D00000067601D00000067614D00000067638D00000067640D00000067644D00000067646D00000067651
- Model/Catalog Number
- Amount recalled
- 960 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.
Want the full recall guide?
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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