Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-80C; Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ventricular fibrillation, that cause Sudden Cardiac Arrest (SCA). There are two models available fully automatic and semi-automatic. After the defibrillations pads are applied to the patient, the fully automatic model evaluates the heart rhythm and, if a shockable rhythm is detected, delivers a shock without any rescuer assistance. The semi-automatic model evaluates the heart rhythm and requires the rescuer to press the shock button if a shockable rhythm is detected. Both models have voice and text instructions that guide the rescuer through the entire defibrillation process. Note: Not all configurations described in this document are available in all areas.

Recall details

Manufacturer

ZOLL Medical Corporation

Distributor

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, VG, ZA.

Lot

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, D00000172506, D00000172563, D00000172565, D00000172571, D00000172572, D00000172583, D00000172589, D00000172592, D00000172616, D00000172742, D00000172985, D00000172991, D00000172999, D00000173001, D00000173008, D00000173019, D00000173025, D00000173043, D00000173048, D00000173050, D00000173056, D00000173057, D00000173061, D00000173062, D00000173067, D00000173068, D00000173069, D00000173070, D00000173071, D00000173074, D00000173079, D00000173091, D00000173093, D00000173094, D00000173095, D00000173096, D00000173097, D00000173099, D00000173100, D00000173102, D00000173104, D00000173107, D00000173111, D00000173114, D00000173115, D00000173116, D00000173122, D00000173125, D00000173132, D00000173133, D00000173135, D00000173137, D00000173138, D00000173145, D00000173146, D00000173147, D00000173151, D00000173152, D00000173154, D00000173155, D00000173170, D00000173218, D00000173219, D00000173220, D00000173222, D00000173231, D00000173238, D00000173244, D00000173247, D00000173321, D00000175078, D00000175082, D00000175148, D00000175165, D00000175190, D00000175192, D00000175194, D00000175196, D00000175209, D00000175211, D00000175225, D00000175229, D00000175251, D00000175253, D00000175254, D00000175268, D00000175342, D00000175750, D00000175752, D00000175755, D00000175756, D00000175758, D00000175759, D00000175765, D00000175766, D00000175767, D00000175768, D00000175770, D00000175772, D00000175773, D00000175774, D00000175775, D00000175776, D00000175780, D00000175792, D00000175809, D00000177781, D00000177794, D00000177803, D00000177805, D00000177811, D00000177812, D00000177813, D00000177814, D00000177815, D00000177817, D00000177818, D00000177823, D00000177824, D00000177826, D00000177827, D00000177831, D00000177846, D00000177848, D00000177849, D00000177850, D00000177851, D00000177852, D00000177853, D00000177854, D00000177855, D00000177856, D00000177861, D00000177862, D00000177863, D00000177865, D00000177867, D00000181120, D00000181132, D00000181153, D00000181165, D00000181179, D00000181198, D00000181203, D00000181206, D00000181212, D00000181233, D00000181250, D00000181253, D00000181267, D00000181290, D00000181294, D00000181309, D00000181310, D00000181329, D00000181334, D00000181347, D00000181352, D00000181367, D00000181372, D00000181876, D00000181881, D00000181960, D00000181964, D00000181965, D00000182004, D00000182016, D00000182017, D00000182025, D00000182037, D00000182040, D00000182193, D00000182196, D00000182198, D00000182212, D00000182243, D00000182276, D00000182285, D00000182

Risk classification

Class II

Area (FDA)

device

Country

United States