ZOLL Medical Corporation: Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-01C, (2) G5A-02C, (3) G5A-05C, (4) G5A-08C, (5) G5A-10C, (6) G5A-13C, (7) G5A-15C, (8) G5A-22C,

Hazard

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

Details from the source

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). 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, Quantity: 960 units Lot/code info: Model/Catalog Number: (1) G5A-01C, (2) G5A-02C, (3) G5A-05C, (4) G5A-08C, (5) G5A-10C, (6) G5A-13C, (7) G5A-15C, (8) G5A-22C, (9) G5A-41C, (10) G5A-85C, (11) G5A-90C (12) G5A-80-L; UDI-DI: (1) 00812394021161, (2) no UDI, (3) no UDI, (4) no UDI, (5) no UDI, (6) no UDI, (7) no UDI, (8) no UDI, (9) no UDI, (10) 00812394021208 (11) no UDI, (12) 00812394021215; Serial Numbers: (1) D00000066618, D00000066630, D00000066659, D00000066773, D00000067078, D00000067079, D00000067081, D00000067082, D00000067086, D00000067088, D00000067092, D00000067094, D00000067097, D00000067099, D00000067100, D00000067103, D00000067108, D00000067109, D00000067114, D00000067117, D00000067129, D00000067133, D00000067135, D00000067136, D00000067138, D00000067139, D00000067143, D00000067145, D00000067171, D00000067172, D00000067174, D00000067178, D00000067180, D00000067183, D00000067184, D00000067186, D00000067192, D00000067195, D00000067197, D00000067199, D00000067204, D00000067209, D00000067212, D00000067217, D00000067219, D00000067224, D00000067233, D00000067235, D00000067267, D00000067303, D00000067384, D00000067456, D00000067577, D00000067601, D00000067614, D00000067638, D00000067640, D00000067644, D00000067646, D00000067651, D00000067652, D00000067653, D00000067654, D00000067655, D00000067658, D00000067660, D00000067664, D00000067665, D00000067666, D00000067667, D00000067668, D00000067669, D00000067696, D00000067697, D00000067714, D00000067748, D00000067755, D00000067756, D00000067758, D00000067762, D

UPC codes

00812394021161, 00812394021208, 00812394021215

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.