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 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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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, D00000033219, D00000033220, D00000033221, D00000033222, D00000033230, D00000035201, D00000035208, D00000035246, D00000035445, D00000035512, D00000035517, D00000035521, D00000035523, D00000035524, D00000035525, D00000035528, D00000035530, D00000035532, D00000035534, D00000035536, D00000035538, D00000035539, D00000035542, D00000035544, D00000035546, D00000035548, D00000035549, D00000035554, D00000035558, D00000035560, D00000035562, D00000035584, D00000035585, D00000035588, D00000035589, D00000035591, D00000035594, D00000035595, D00000035599, D00000035601, D00000035603, D00000035605, D00000035607, D00000035610, 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- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- ZOLL Medical Corporation
- Reason for Recall:
- The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
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 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.
Product Codes/Lot Numbers:
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, D00000033219, D00000033220, D00000033221, D00000033222, D00000033230, D00000035201, D00000035208, D00000035246, D00000035445, D00000035512, D00000035517, D00000035521, D00000035523, D00000035524, D00000035525, D00000035528, D00000035530, D00000035532, D00000035534, D00000035536, D00000035538, D00000035539, D00000035542, D00000035544, D00000035546, D00000035548, D00000035549, D00000035554, D00000035558, D00000035560, D00000035562, D00000035584, D00000035585, D00000035588, D00000035589, D00000035591, D00000035594, D00000035595, D00000035599, D00000035601, D00000035603, D00000035605, D00000035607, D00000035610, D00000035614, D00000035825, 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D00000057086, D00000057114, D00000057123, D00000057126, D00000057127, D00000057128, D00000057129, D00000057132, D00000057145, D00000057157, D00000057160, D00000057163, D00000057168, D00000057170, D00000057171, D00000057172, D00000057173, D00000057174, D00000057175, D00000057176, D00000057177, D00000057178, D00000057179, D00000057180, D00000057193, D00000057225, D00000057236, D00000057245, D00000057248, D00000057249, D00000057251, D00000057252, D00000057253, D00000057254, D00000057256, D00000057258, D00000057269, D00000057276, D00000057282, D00000057296, D00000057524, D00000057564, D00000057566, D00000057567, D00000057568, D00000057570, D00000057571, D00000057572, D00000057573, D00000057574, D00000057575, D00000057576, D00000057577, D00000057578, D00000057579, D00000057580, D00000057581, D00000057582, D00000057583, D00000057584, D00000057585, D00000057586, D00000057588, D00000057590, D00000057591, D00000057592, D00000057593, D00000057594, D00000057595, D00000057602, D00000057603, D00000057604, D00000057605, D00000057606, D00000057607, D00000057608, D00000057609, D00000057610, D00000057611, D00000057612, D00000057613, D00000057614, D00000057615, D00000057616, D00000057617, D00000057618, D00000057619, D00000057620, D00000057621, D00000057622, D00000057623, D00000057624, D00000057625, D00000057626, D00000057627, D00000057628, D00000057629, D00000057630, D00000057631, D00000057632, D00000057633, D00000057634, D00000057635, D00000057636, D00000057637, D00000057638, D00000057639, D00000057640, D00000057641, D00000057642, D00000057643, D00000057644, D00000057645, D00000057646, D00000057647, D00000057648, D00000057649, D00000057650, D00000057651, D00000057652, D00000057653, D00000057654, D00000057655, D00000057657, D00000057658, D00000057659, D00000057660, D00000057661,
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1318-2025
Related Recalls
The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).