ZOLL Powerheart G5 AED May Fail Self-Test in Extreme Conditions
The ZOLL Powerheart G5 automated external defibrillator may fail its self-test after prolonged exposure to extreme temperatures or humidity levels. This could prevent proper device functioning in an emergency.
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 involving a medical device that poses a risk to patient safety if it fails during use. No illnesses or injuries have been reported. The hazard is a potential device malfunction triggered by environmental exposure, making this a risk-of-harm situation without reported adverse events.
Plain-English summary
The ZOLL Powerheart G5 automated external defibrillator (AED) is being recalled due to a potential safety issue. Affected models include G5A-00A, G5A-01A, G5A-02A, G5A-03A, G5A-19A, G5A-80A, and G5A-80A-TSO, with approximately 2,268 units distributed nationwide in the United States and internationally.
The devices may fail their self-test as a result of prolonged exposure to extreme environments, such as elevated temperatures or high humidity levels. The self-test is an important safety feature that verifies the device is functioning correctly before it is needed in an emergency.
If you own or operate one of these devices, check that your model and serial number match those listed in the FDA recall notice. Contact ZOLL Medical Corporation for instructions on how to address the issue with your device. Do not rely on a device that fails its self-test.
The recalled product
- Product
- Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-00A, (2) G5A-01A, (3) G5A-02A, (4) G5A-03A, (5) G5A-19A, (6) G5A-80A, (7) G5A-80A-TSO. Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed
- 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: (1) G5A-00A
- (2) G5A-01A
- (3) G5A-02A
- (4) G5A-03A
- (5) G5A-19A
- (6) G5A-80A
- (7) G5A-80A-TSO
- UDI-DI: (1) no UDI
- (2) 00812394021154
- (3) no UDI
- (4) no UDI
- (5) 00812394022243
- (6) 00812394021192
- (7) 00812394021390
- Serial Numbers: (1) D00000177884
- D00000177917
- D00000177931
- D00000177956
- D00000178271
- D00000178311
Distribution
Distributed nationwide across the United States.
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