ZOLL Powerheart G5 AED may fail self-test in extreme environments
ZOLL is recalling certain Powerheart G5 automated external defibrillators (AED) due to the potential for devices to fail their self-test when exposed to extreme temperatures or humidity.
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 FDA Class II recall addresses a potential malfunction in a life-critical cardiac emergency device. The hazard remains theoretical without reported device failures or patient injuries, but the potential consequence of device failure in an emergency situation justifies a High severity rating.
Plain-English summary
ZOLL Medical Corporation is recalling Powerheart G5 automated external defibrillators (AED), models G5A-80C and G5A-80C-TSO. Approximately 63,607 units were distributed domestically throughout the United States and internationally.
The recalled devices have the potential to fail their self-test when exposed to prolonged periods of extreme temperature and/or humidity. This self-test failure could prevent the device from functioning properly in a cardiac emergency.
Patients and healthcare facilities with these AED devices should verify their device serial numbers against the manufacturer's recall information. Contact ZOLL Medical Corporation directly for instructions on device evaluation and any necessary replacement or service.
The recalled product
- Product
- Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-80C, (2) G5A-80C-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
- 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-80C
- (2) G5A-80C-TSO
- UDI-DI: (1) 00812394021208
- (2) 00812394021406
- Serial Numbers: (1) D00000022708
- D00000033165
- D00000033168
- D00000033171
- D00000033174
- D00000033185
- D00000033187
- D00000033189
- D00000033191
- D00000033208
- D00000033209
- D00000033211
- D00000033213
- D00000033214
- D00000033216
- D00000033217
Distribution
Distributed nationwide across the United States.
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