ZOLL Powerheart G5 AED devices may fail self-test in extreme environments
ZOLL is recalling Powerheart G5 AED devices that may fail their self-test when exposed to extreme temperature or humidity, potentially affecting proper device operation.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a critical life-saving device where potential self-test failure could prevent emergency treatment of cardiac arrhythmias. No illnesses or injuries have been reported. The hazard is theoretical with no reported harm on a high-risk product, which per the rubric rates as High (3).
Plain-English summary
ZOLL Medical Corporation is recalling 7,221 Powerheart G5 AED devices (Model G5S-80C). The devices may fail their self-test following prolonged exposure to extreme environmental conditions, specifically extreme temperature and/or humidity.
The self-test function is critical—it verifies that the AED is operating properly before use in treating life-threatening heart rhythms such as ventricular fibrillation. A failed self-test could prevent the device from functioning when needed in an emergency.
The recall affects devices distributed nationwide and in multiple countries internationally. Users should verify that their devices are functioning properly and should contact ZOLL Medical Corporation if they have concerns about their device's status or need guidance on replacement or repair options.
The recalled product
- Product
- Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-80C; Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ventricular fibrilla
- Manufacturer
- ZOLL Medical Corporation
- Hazard
- self-test-failure
- environmental-exposure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model/Catalog Number: G5S-80C
- UDI-DI: 00812394021284
- Serial Numbers: D00000171086
- D00000171087
- D00000171088
- D00000171089
- D00000171090
- D00000171092
- D00000171093
- D00000171094
- D00000171095
- D00000171096
- D00000171097
- D00000171098
- D00000171099
- D00000171100
- D00000171101
- D00000171102
- D00000171103
- D00000171105
Distribution
Distributed nationwide across the United States.
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