Reported Mar 19, 2025 · Ongoing
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-80A, (2) G5A-80A-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-80A(2) 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-80A(2) G5A-80A-TSO
- UDI-DI
(1) 00812394021192(2) 00812394021390
- Serial Numbers
2,321 of 2,321 codes
D00000003715D00000003785D00000003909D00000003916D00000003920D00000003937D00000003940D00000003946D00000003948D00000003953D00000003969D00000003975D00000004007D00000004008D00000004009D00000004010D00000004012D00000004014D00000004016D00000004017D00000004018D00000004020D00000004023D00000004024D00000004025D00000004027D00000004028D00000004029D00000004030D00000004032D00000004033D00000004034D00000004035D00000004038D00000004039D00000004041D00000004042D00000004044D00000004045D00000004047D00000004049D00000004050D00000004051D00000004052D00000004053D00000004054D00000004055D00000004056D00000004057D00000004079D00000004097D00000004103D00000004106D00000004108D00000004122D00000004124D00000004127D00000004134D00000004135D00000004136
- Model/Catalog Number
- Amount recalled
- 56,981 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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