ZOLL Powerheart G5 AED Self-Test May Fail Under Extreme Environmental Conditions
ZOLL is recalling certain Powerheart G5 AED units that may fail their self-test when exposed to extreme temperatures or humidity. The affected devices could fail to function properly in emergencies.
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: FDA Class II recall of a life-critical medical device where no adverse events have been reported. The hazard is potential device self-test failure under extreme environmental conditions (temperature/humidity). This qualifies as high severity because the product is risk-of-harm (AED for cardiac emergencies), though no injuries have been reported.
Plain-English summary
ZOLL Medical Corporation is recalling specific Powerheart G5 AED units due to a self-test failure risk. The automated external defibrillator (AED) is designed to treat life-threatening cardiac arrhythmias during sudden cardiac arrest.
The devices have the potential to fail their self-test as a result of prolonged exposure to extreme environments, including extreme temperatures and/or humidity. This failure could prevent the device from operating properly if needed during a cardiac emergency.
The recalled units were distributed nationwide in the United States and to approximately 50 countries. Specific model numbers and serial numbers have been identified for affected devices.
Customers with affected units should contact ZOLL Medical Corporation. Users should verify their device's model and serial number against the official recall information to determine if their unit is affected.
The recalled product
- Product
- Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5S-00A-TSO, (2) G5S-01A, (3) G5S-02A, (4) G5S-05A, (5) G5S-08A, (6) G5S-10A, (7) G5S-11A, (8) G5S-80A-TSO, (9) G5S-80-L (10) G5S-90A; Software Version: NA Product Description: The Powerheart G5 automa
- Manufacturer
- ZOLL Medical Corporation
- Hazard
- self-test-failure
- extreme-temperature
- extreme-humidity
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) G5S-00A-TSO
- (2) G5S-01A
- (3) G5S-02A
- (4) G5S-05A
- (5) G5S-08A
- (6) G5S-10A
- (7) G5S-11A
- (8) G5S-80A-TSO
- (9)G5S-80-L
- (10) G5S-90A
- UDI-DI: (1) no UDI
- (2) 00812394021239
- (3) no UDI
- (4) no UDI
- (5) no UDI
- (6) no UDI
- (7) no UDI
- (8) 00812394021413
- (9) no UDI
- (10) no UDI
Distribution
Distributed nationwide across the United States.
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