Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-80A; 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.

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🏥 Medical Devices Recalled: February 13, 2025 ZOLL Medical Infusion Pumps Nationwide

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    Model/Catalog Number: G5S-80A; UDI-DI: 00812394021277; Serial Numbers: D00000003974, D00000004048, D00000004128, D00000004404, D00000004436, D00000004556, D00000004560, D00000004563, D00000004564, D00000004573, D00000004581, D00000004582, D00000004642, D00000004665, D00000004666, D00000004718, D00000004730, D00000004736, D00000004743, D00000004744, D00000004750, D00000004770, D00000004774, D00000004779, D00000004780, D00000004784, D00000004785, D00000004787, D00000004789, D00000004794, D00000004799, D00000004800, D00000004801, D00000004802, D00000004805, D00000004806, D00000004807, D00000004808, D00000004809, D00000004810, D00000004812, D00000004815, D00000004816, D00000004818, D00000004820, D00000004821, D00000004824, D00000004873, D00000004916, D00000004929, D00000004933, D00000004939, D00000004940, D00000004951, D00000004955, D00000004960, D00000004970, D00000004974, D00000004976, D00000004983, D00000006293, D00000006294, D00000006296, D00000006338, D00000006341, D00000006343, 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  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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: G5S-80A; 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: G5S-80A; UDI-DI: 00812394021277; Serial Numbers: D00000003974, D00000004048, D00000004128, D00000004404, D00000004436, D00000004556, D00000004560, D00000004563, D00000004564, D00000004573, D00000004581, D00000004582, D00000004642, D00000004665, D00000004666, D00000004718, D00000004730, D00000004736, D00000004743, D00000004744, D00000004750, D00000004770, D00000004774, D00000004779, D00000004780, D00000004784, D00000004785, D00000004787, D00000004789, D00000004794, D00000004799, D00000004800, D00000004801, D00000004802, D00000004805, D00000004806, D00000004807, D00000004808, D00000004809, D00000004810, D00000004812, D00000004815, D00000004816, D00000004818, D00000004820, D00000004821, D00000004824, D00000004873, D00000004916, D00000004929, D00000004933, D00000004939, D00000004940, D00000004951, D00000004955, D00000004960, D00000004970, D00000004974, D00000004976, D00000004983, D00000006293, D00000006294, D00000006296, D00000006338, D00000006341, D00000006343, 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Official Source

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FDA Recall Number: Z-1323-2025

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