Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-80C; 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 - Dangerous
🏥 Medical Devices Recalled: February 13, 2025 ZOLL Medical Infusion Pumps Nationwide

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    Model/Catalog Number: G5S-80C; UDI-DI: 00812394021284; Serial Numbers: D00000171086, D00000171087, D00000171088, D00000171089, D00000171090, D00000171092, D00000171093, D00000171094, D00000171095, D00000171096, D00000171097, D00000171098, D00000171099, D00000171100, D00000171101, D00000171102, D00000171103, D00000171105, D00000171107, D00000171109, D00000171111, D00000171113, D00000171115, D00000171117, D00000171118, D00000171121, D00000171126, D00000171133, D00000171134, D00000171136, D00000171138, D00000171140, D00000171144, D00000171147, D00000171150, D00000171154, D00000171157, D00000171159, D00000171160, D00000171164, D00000171165, D00000171166, D00000171167, D00000171168, D00000171169, D00000171170, D00000171171, D00000171172, D00000171178, D00000171179, D00000171181, D00000171183, D00000171186, D00000171188, D00000171190, D00000171601, D00000172373, D00000172376, D00000172379, D00000172381, D00000172382, D00000172383, D00000172384, D00000172385, D00000172386, D00000172391, 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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-80C; 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-80C; UDI-DI: 00812394021284; Serial Numbers: D00000171086, D00000171087, D00000171088, D00000171089, D00000171090, D00000171092, D00000171093, D00000171094, D00000171095, D00000171096, D00000171097, D00000171098, D00000171099, D00000171100, D00000171101, D00000171102, D00000171103, D00000171105, D00000171107, D00000171109, D00000171111, D00000171113, D00000171115, D00000171117, D00000171118, D00000171121, D00000171126, D00000171133, D00000171134, D00000171136, D00000171138, D00000171140, D00000171144, D00000171147, D00000171150, D00000171154, D00000171157, D00000171159, D00000171160, D00000171164, D00000171165, D00000171166, D00000171167, D00000171168, D00000171169, D00000171170, D00000171171, D00000171172, D00000171178, D00000171179, D00000171181, D00000171183, D00000171186, D00000171188, D00000171190, D00000171601, D00000172373, D00000172376, D00000172379, D00000172381, D00000172382, D00000172383, D00000172384, D00000172385, D00000172386, D00000172391, 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FDA Recall Number: Z-1321-2025

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