ZOLL Medical Corporation: Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-80A; Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (

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: 8,744 units Lot/code info: Model/Catalog Number: G5S-80A; UDI-DI: 00812394021277; Serial Numbers: D00000003974, D00000004048, D00000004128, D00000004404, D00000004436, D00000004556, D00000004560, D00000004563, D00000004564, D00000004573, D00000004581, D00000004582, D00000004642, D00000004665, D00000004666, D00000004718, D00000004730, D00000004736, D00000004743, D00000004744, D00000004750, D00000004770, D00000004774, D00000004779, D00000004780, D00000004784, D00000004785, D00000004787, D00000004789, D00000004794, D00000004799, D00000004800, D00000004801, D00000004802, D00000004805, D00000004806, D00000004807, D00000004808, D00000004809, D00000004810, D00000004812, D00000004815, D00000004816, D00000004818, D00000004820, D00000004821, D00000004824, D00000004873, D00000004916, D00000004929, D00000004933, D00000004939, D00000004940, D00000004951, D00000004955, D00000004960, D00000004970, D00000004974, D00000004976, D00000004983, D00000006293, D00000006294, D00000006296, D00000006338, D00000006341, D00000006343, D00000006851, D00000006852, D00000006893, D00000006894, D00000006904, D00000006915, D00000006918, D00000006921, D00000006925, D00000006928, D00000006931, D00000006975, D00000006976, D00000006989, D00000006990, D00000006991, D00000006992, D00000006994, D00000006998, D00000007012, D00000007237, D00000007238, D00000007239, D00000007241, D00000007242, D00000007243, D00000007244, D00000007245, D00000007249, D00000007252, D00000007254, D00000007255, D00000007256, D00000007257, D00000007258, D00000007259, D

UPC codes

00812394021277

Source

Official record: FDA (Device enforcement) ↗

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