ZOLL Medical Corporation: Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-80C; 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: 7,221 units Lot/code info: Model/Catalog Number: G5S-80C; UDI-DI: 00812394021284; Serial Numbers: D00000171086, D00000171087, D00000171088, D00000171089, D00000171090, D00000171092, D00000171093, D00000171094, D00000171095, D00000171096, D00000171097, D00000171098, D00000171099, D00000171100, D00000171101, D00000171102, D00000171103, D00000171105, D00000171107, D00000171109, D00000171111, D00000171113, D00000171115, D00000171117, D00000171118, D00000171121, D00000171126, D00000171133, D00000171134, D00000171136, D00000171138, D00000171140, D00000171144, D00000171147, D00000171150, D00000171154, D00000171157, D00000171159, D00000171160, D00000171164, D00000171165, D00000171166, D00000171167, D00000171168, D00000171169, D00000171170, D00000171171, D00000171172, D00000171178, D00000171179, D00000171181, D00000171183, D00000171186, D00000171188, D00000171190, D00000171601, D00000172373, D00000172376, D00000172379, D00000172381, D00000172382, D00000172383, D00000172384, D00000172385, D00000172386, D00000172391, D00000172412, D00000172413, D00000172414, D00000172416, D00000172421, D00000172422, D00000172425, D00000172426, D00000172428, D00000172430, D00000172431, D00000172432, D00000172433, D00000172434, D00000172435, D00000172436, D00000172437, D00000172438, D00000172439, D00000172444, D00000172446, D00000172448, D00000172449, D00000172455, D00000172466, D00000172473, D00000172482, D00000172483, D00000172484, D00000172486, D00000172487, D00000172488, D00000172489, D00000172493, D00000172497, D00000172503, D

UPC codes

00812394021284

Source

Official record: FDA (Device enforcement) ↗

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