ZOLL Powerheart G5 AED May Fail Self-Test After Environmental Exposure
ZOLL Powerheart G5 AED devices may fail their self-test if exposed to extreme temperatures or humidity. Approximately 56,981 units are being recalled nationwide and internationally.
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 medical device recall affecting a life-critical product (automated external defibrillator) where a potential malfunction (self-test failure) could lead to patient harm if the device fails to operate during a cardiac emergency. No actual illnesses or injuries are reported, but the risk-of-harm nature of the product warrants a High severity rating per the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
ZOLL Medical Corporation is recalling approximately 56,981 units of the Powerheart G5 automated external defibrillator (AED). The recalled devices are models G5A-80A and G5A-80A-TSO, distributed nationwide in the United States and internationally.
The devices may fail their self-test function if exposed to prolonged extreme temperatures or humidity. A self-test failure could prevent the AED from functioning properly during a cardiac emergency.
Users of these devices should verify proper storage conditions and monitor device performance to ensure reliable operation when needed.
The recalled product
- Product
- Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-80A, (2) G5A-80A-TSO. Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as
- Manufacturer
- ZOLL Medical Corporation
- Category
- Medical Device — Defibrillator
- Hazard
- device-malfunction
- 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: (1) G5A-80A
- (2) G5A-80A-TSO
- UDI-DI: (1) 00812394021192
- (2) 00812394021390
- Serial Numbers: D00000003715
- D00000003785
- D00000003909
- D00000003916
- D00000003920
- D00000003937
- D00000003940
- D00000003946
- D00000003948
- D00000003953
- D00000003969
- D00000003975
- D00000004007
- D00000004008
- D00000004009
- D00000004010
Distribution
Distributed nationwide across the United States.
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