ZOLL Powerheart G5 AED shipping film may prevent shock delivery
ZOLL Powerheart G5 AED devices are shipped with a protective film on the front panel. If not removed before use, the film may prevent the shock button from being pressed, delaying or preventing defibrillation therapy.
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 with no reported illnesses or injuries. However, the protective film prevents operation of a life-critical medical device used to treat sudden cardiac arrest. This meets the criterion for High severity: a risk-of-harm product where injury has not yet been reported.
Plain-English summary
ZOLL Powerheart G5 AED devices are shipped with a clear protective film on the front panel that protects the screen and shock button from cosmetic damage during shipping. The G5 is an automated external defibrillator designed to treat life-threatening heart rhythm problems, such as ventricular fibrillation, that cause sudden cardiac arrest.
If the protective film is not removed from the front bezel before the device is deployed in an emergency, it may prevent the user from pressing the shock button. This failure could delay or prevent the delivery of defibrillation therapy to a person suffering from sudden cardiac arrest.
Affected models include G5S-00A, G5S-00A-TSO, G5S-00C, G5S-01A, G5S-02A, G5S-02C, G5S-02-L, G5S-04A, G5S-05A, G5S-05C, G5S-06A, G5S-06C, G5S-08A, G5S-08C, G5S-10A, G5S-10C, G5S-11A, G5S-11C, G5S-12C, G5S-13A, G5S-14A, G5S-15A, G5S-17A, G5S-17C, G5S-19A, G5S-23C, G5S-29A, G5S-29C, G5S-31A, G5S-31A-SJA, G5S-31C-SJA, G5S-36A, G5S-37A, G5S-41A, G5S-41C, G5S-80A, G5S-80A-TSO, G5S-80C, G5S-80-L, G5S-82A, G5S-82C, G5S-83C, and G5S-90C. Serial numbers D00000276194 through D00000343449 are affected.
If you own or operate one of these devices, verify that the protective film has been completely removed from the front bezel before deployment. Contact Zoll Medical Corporation for additional instructions if needed.
The recalled product
- Product
- ZOLL Powerheart G5 AED, Semi-Automatic, G5Sxxx Family -Automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ventricular fibrillation, that cause Sudden Cardiac Arrest (SCA). Model/Catalog Number: G5S-00A G5S-0
- Manufacturer
- Zoll Medical Corporation
- Affected units
- 14,885
Distribution
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