ZOLL Medical Corporation: Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-80C, (2) G5A-80C-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: 63,607 units Lot/code info: Model/Catalog Number: (1) G5A-80C, (2) G5A-80C-TSO; UDI-DI: (1) 00812394021208, (2) 00812394021406; Serial Numbers: (1) D00000022708, D00000033165, D00000033168, D00000033171, D00000033174, D00000033185, D00000033187, D00000033189, D00000033191, D00000033208, D00000033209, D00000033211, D00000033213, D00000033214, D00000033216, D00000033217, D00000033219, D00000033220, D00000033221, D00000033222, D00000033230, D00000035201, D00000035208, D00000035246, D00000035445, D00000035512, D00000035517, D00000035521, D00000035523, D00000035524, D00000035525, D00000035528, D00000035530, D00000035532, D00000035534, D00000035536, D00000035538, D00000035539, D00000035542, D00000035544, D00000035546, D00000035548, D00000035549, D00000035554, D00000035558, D00000035560, D00000035562, D00000035584, D00000035585, D00000035588, D00000035589, D00000035591, D00000035594, D00000035595, D00000035599, D00000035601, D00000035603, D00000035605, D00000035607, D00000035610, D00000035614, D00000035825, D00000035839, D00000035877, D00000036255, D00000036259, D00000036262, D00000036264, D00000036267, D00000036274, D00000036309, D00000036324, D00000036334, D00000036337, D00000036339, D00000036360, D00000036472, D00000036509, D00000036640, D00000036729, D00000036731, D00000036732, D00000036746, D00000036748, D00000036749, D00000036750, D00000036751, D00000036752, D00000036754, D00000036755, D00000036756, D00000036757, D00000036758, D00000036759, D00000036874, D00000036875, D00000036877, D00000036878, D0000003

UPC codes

00812394021208, 00812394021406

Source

Official record: FDA (Device enforcement) ↗

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