FDA Medical devices recall · March 19, 2025

ZOLL Product Name: Powerheart G5 AED Model recall

Read the official FDA notice ↗

Product

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.

Why was it recalled?

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

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

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, D00000004427, D00000004441, D00000004464, D00000004509, D00000004515, D00000004516, D00000004654, D00000004658, D00000004659, D00000004669, D00000004672, D00000004673, D00000004698, D00000004703, D00000004716, D00000004841, D00000004855, D00000004857, D00000004869, D00000004880, D00000004889, D00000004891, D00000004897, D00000005194, D00000005204, D00000005207, D00000005208, D00000005218, D00000005220, D00000005230, D00000005235, D00000007936, D00000007937, D00000007938, D00000007942, D00000007961, D0000000

Distribution

Domestic: Nationwide Distribution International: AE, AI, AM, AR, AT, AU, BD, BE, BG, BH, BM, BN, BS, CA, CH, CL, CN, CO, CR, CZ, DE, DK, DO, EG, ES, FI, FR, GB, GH, GU, HK, HR, HU, ID, IE, IL, IN, IS, IT, JE, JM, JP, KR, KW, KZ, LB, LT, MA, MC, MD, ME, MQ, MS, MT, MX, MY, NC, NG, NL, NO, NZ, OM, PA, PE, PG, PH, PK, PL, PR, PT, QA, RE, RO, RS, RU, SA, SE, SG, SI, SK, SM, TC, TH, TN, TR, TW, UA, US, VG, ZA.

States: Arkansas California Colorado Delaware Idaho Illinois Indiana Massachusetts Maryland Maine Mississippi Montana North Carolina Pennsylvania Puerto Rico Tennessee

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (medical devices), recall Z-1322-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.