ZOLL Medical Corporation: Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-80A, (2) G5A-80A-TSO. Software Version: NA Product Description: The Powerheart G5 automated ext

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: 56,981 units Lot/code info: Model/Catalog Number: (1) G5A-80A, (2) G5A-80A-TSO; UDI-DI: (1) 00812394021192, (2) 00812394021390; Serial Numbers: D00000003715, D00000003785, D00000003909, D00000003916, D00000003920, D00000003937, D00000003940, D00000003946, D00000003948, D00000003953, D00000003969, D00000003975, D00000004007, D00000004008, D00000004009, D00000004010, D00000004012, D00000004014, D00000004016, D00000004017, D00000004018, D00000004020, D00000004023, D00000004024, D00000004025, D00000004027, D00000004028, D00000004029, D00000004030, D00000004032, D00000004033, D00000004034, D00000004035, D00000004038, D00000004039, D00000004041, D00000004042, D00000004044, D00000004045, D00000004047, D00000004049, D00000004050, D00000004051, D00000004052, D00000004053, D00000004054, D00000004055, D00000004056, D00000004057, D00000004079, D00000004097, D00000004103, D00000004106, D00000004108, D00000004122, D00000004124, D00000004127, D00000004134, D00000004135, D00000004136, D00000004137, D00000004139, D00000004144, D00000004195, D00000004198, D00000004200, D00000004202, D00000004210, D00000004212, D00000004218, D00000004222, D00000004223, D00000004228, D00000004232, D00000004236, D00000004237, D00000004239, D00000004244, D00000004245, D00000004250, D00000004251, D00000004252, D00000004256, D00000004260, D00000004264, D00000004265, D00000004275, D00000004307, D00000004315, D00000004377, D00000004380, D00000004382, D00000004383, D00000004385, D00000004386, D00000004387, D00000004391, D00000004392, D00000004395

UPC codes

00812394021192, 00812394021390

Source

Official record: FDA (Device enforcement) ↗

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