Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5S-00A-TSO, (2) G5S-01A, (3) G5S-02A, (4) G5S-05A, (5) G5S-08A, (6) G5S-10A, (7) G5S-11A, (8) G5S-80A-TSO, (9) G5S-80-L (10) G5S-90A; 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

What Should You Do?

  1. Check if you have this product:
    Model/Catalog Number: (1) G5S-00A-TSO, (2) G5S-01A, (3) G5S-02A, (4) G5S-05A, (5) G5S-08A, (6) G5S-10A, (7) G5S-11A, (8) G5S-80A-TSO, (9)G5S-80-L, (10) G5S-90A; UDI-DI: (1) no UDI, (2) 00812394021239, (3) no UDI, (4) no UDI, (5) no UDI, (6) no UDI, (7) no UDI, (8) 00812394021413, (9) no UDI, (10) no UDI; Serial Numbers: (1) D00000154575, D00000154617, (2) D00000003725, D00000003727, D00000003734, D00000003896, D00000003898, D00000003923, D00000003927, D00000003941, D00000003943, D00000003951, D00000003955, D00000003962, D00000003964, D00000003965, D00000003968, D00000003971, D00000003972, D00000003981, D00000003982, D00000003984, D00000003987, D00000003989, D00000003991, D00000003997, D00000003999, D00000004149, D00000004151, D00000004153, D00000004154, D00000004156, D00000004158, D00000004301, D00000004304, D00000004308, D00000004313, D00000004324, D00000004329, D00000004365, D00000004390, D00000004394, D00000004402, D00000004407, D00000004408, D00000004410, D00000004413, 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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: (1) G5S-00A-TSO, (2) G5S-01A, (3) G5S-02A, (4) G5S-05A, (5) G5S-08A, (6) G5S-10A, (7) G5S-11A, (8) G5S-80A-TSO, (9) G5S-80-L (10) G5S-90A; 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) G5S-00A-TSO, (2) G5S-01A, (3) G5S-02A, (4) G5S-05A, (5) G5S-08A, (6) G5S-10A, (7) G5S-11A, (8) G5S-80A-TSO, (9)G5S-80-L, (10) G5S-90A; UDI-DI: (1) no UDI, (2) 00812394021239, (3) no UDI, (4) no UDI, (5) no UDI, (6) no UDI, (7) no UDI, (8) 00812394021413, (9) no UDI, (10) no UDI; Serial Numbers: (1) D00000154575, D00000154617, (2) D00000003725, D00000003727, D00000003734, D00000003896, D00000003898, D00000003923, D00000003927, D00000003941, D00000003943, D00000003951, D00000003955, D00000003962, D00000003964, D00000003965, D00000003968, D00000003971, D00000003972, D00000003981, D00000003982, D00000003984, D00000003987, D00000003989, D00000003991, D00000003997, D00000003999, D00000004149, D00000004151, D00000004153, D00000004154, D00000004156, D00000004158, D00000004301, D00000004304, D00000004308, D00000004313, D00000004324, D00000004329, D00000004365, D00000004390, D00000004394, D00000004402, D00000004407, D00000004408, D00000004410, D00000004413, 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D00000270265, M00000002042, M00000015317, M00000015355, M00000015411, M00000015413, M00000015416, M00000015420, M00000015480, M00000015489, M00000015540, M00000015544, M00000015557, M00000015576, M00000015642, M00000015677, M00000015696, M00000015748, M00000015781, M00000015812, M00000015818, M00000015819, M00000015890, M00000015895, M00000015902, M00000015919, M00000015923, M00000015960, M00000015965, (3) D00000002496, D00000195191, (4) D00000228356, (5) D00000095452, (6) D00000023456, M00000001511, (7) M00000006322, (8) D00000247707, D00000247709, D00000247717, D00000247721, D00000247722, D00000247723, D00000247724, D00000247725, D00000247726, D00000247728, D00000247738, D00000247741, D00000247786, D00000247792, D00000247796, D00000247803, D00000247805, D00000247806, (9) D00000025111, D00000029078, (10) D00000035676, D00000176940;

Official Source

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FDA Recall Number: Z-1322-2025

Related Recalls

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

Feb 13, 2025 Infusion Pumps Nationwide View Details →

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

Feb 13, 2025 Infusion Pumps Nationwide View Details →

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

Feb 13, 2025 Infusion Pumps Nationwide View Details →