Reported Mar 19, 2025 · Ongoing
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5S-01C, (2) G5S-02C, (3) G5S-10C, (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-01C(2) G5S-02C(3) G5S-10C(4) G5S-11C
- 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-01C(2) G5S-02C(3) G5S-10C(4) G5S-11C
- UDI-DI
(1) 00812394021246(2) no UDI(3) no UDI(4) no UDI
- Serial Numbers
73 of 73 codes
(1) D00000089561D00000089566D00000089577D00000105587D00000111542D00000111556D00000111640D00000111706D00000111718D00000113136D00000113147D00000113175D00000113177D00000113178D00000113180D00000113181D00000113182D00000113199D00000113200D00000113201D00000113205D00000113206D00000113207D00000134850D00000134892D00000135125D00000136870D00000136917D00000136954D00000157288D00000170036D00000170073D00000172554D00000178309D00000178332D00000183632D00000191330D00000191339D00000191347D00000191349D00000191362D00000191363D00000191366D00000221153D00000221179D00000221199D00000221200D00000221206D00000221208D00000221211D00000221235D00000221237D00000221245D00000221247D00000221257D00000221263D00000221265D00000221267D00000221273D00000221279
- Model/Catalog Number
- Amount recalled
- 73 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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