medical Class II Updated 2025-03-19

ZOLL Medical Corporation recalls Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Cat

Recalled Product

Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5S-01C, (2) G5S-02C, (3) G5S-10C, (4) G5S-11C; Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ventricular fibrillation, that cause Sudden Cardiac Arrest (SCA). There are two models available fully automatic and semi-automatic. After the defibrillations pads are applied to the patient, the fully automatic model evaluates the heart rhythm and, if a shockable rhythm is detected, delivers a shock without any rescuer assistance. The semi-automatic model evaluates the heart rhythm and requires the rescuer to press the shock button if a shockable rhythm is detected. Both models have voice and text instructions that guide the rescuer through the entire defibrillation process. Note: Not all configurations described in this document are available in all areas.

Hazard / Issue

The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Model/Catalog Number: (1) G5S-01C, (2) G5S-02C, (3) G5S-10C, (4) G5S-11C; UDI-DI: (1) 00812394021246, (2) no UDI, (3) no UDI, (4) no UDI; Serial Numbers: (1) D00000089561, D00000089566, D00000089577, D00000105587, D00000111542, D00000111556, D00000111640, D00000111706, D00000111718, D00000113136, D00000113147, D00000113175, D00000113177, D00000113178, D00000113180, D00000113181, D00000113182, D00000113199, D00000113200, D00000113201, D00000113205, D00000113206, D00000113207, D00000134850, D00000134892, D00000135125, D00000136870, D00000136917, D00000136954, D00000157288, D00000170036, D00000170073, D00000172554, D00000178309, D00000178332, D00000183632, D00000191330, D00000191339, D00000191347, D00000191349, D00000191362, D00000191363, D00000191366, D00000221153, D00000221179, D00000221199, D00000221200, D00000221206, D00000221208, D00000221211, D00000221235, D00000221237, D00000221245, D00000221247, D00000221257, D00000221263, D00000221265, D00000221267, D00000221273, D00000221279, D00000221283, (2)D00000004566, D00000004687, D00000004688, D00000005214, D00000017929, D00000067528, D00000067585, D00000067595, D00000067685, D00000155123, (3) D00000171086, (4) M00000005364;
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