medical Class II Updated 2018-08-29

GE Healthcare Japan Corporation recalls GE Healthcare Optima CT660. The systems are intended for he

Recalled Product

GE Healthcare Optima CT660. The systems are intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. Sold only outside the U.S. under the following product names: CT OPTIMA 660, CT OPTIMA 660 LONG BJG SKD RUS, CT OPTIMA 660 LONG BJG SKD RUSSIA, CT OPTIMA 660 MID BJG SKD RUSSIA, CT OPTIMA 660 SE, CT OPTIMA 660 SE ASIR, CT660 M40 LONG, CT660 M40 MID, CT660 M40 MID WAUK SKD, CT660 M40 MID WAUK SKD BRAZ, CT660 M40 MID WAUK SKD BRAZ, OPT 660 M40 MID HINO SKD RUS, OPTIMA 660, OPTIMA 660 1.5, OPTIMA 660 1.5 BRAZIL, OPTIMA 660 1.5 BRAZIL SKD W, OPTIMA 660 1.5 BRAZIL SKD WAUK, OPTIMA 660 LONG BJG, OPTIMA 660 M40, OPTIMA 660 M40 3.5 LONG BJG, OPTIMA 660 M40 LONG BJG, OPTIMA 660 M40 LONG BJG SKD RUSS, OPTIMA 660 M40 MID BJG, OPTIMA 660 M40 MID BJG SKD RUSS, OPTIMA 660 MID BJG, OPTIMA 660 MID BJG SKD, OPTIMA CT 660, OPTIMA CT660, OPTIMA CT660 ASIR 128 M RU, OPTIMA CT660 FREEDOM LG HN2.5, OPTIMA CT660 FREEDOM MD BJG2.5, OPTIMA CT660 MID P1.5 HINO, OPTIMA CT660 SE ASIR, OPTIMA CT660 SE GT 1700 HN2.5, OPTIMA CT660 SE GT 2000 BJG2.5, OPTIMA CT660 SKD BRAZIL, OPTIMA CT660S L RU

Hazard / Issue

GE Healthcare has identified that some CT systems may have a damaged cable that can expose 120VAC to Service Engineers working inside the gantry.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Model Number, Serial Number (System ID): 6375965-146, CJRSX1600007CN (CJRSX1600007CN); 6375965-146, CJRSX1600001CN (CJRSX1600001CN); 6375965-100, 00000433543CN6 (CT433543CN6); 6375965-100, 00000438341CN0 (CT438341CN0); 6375965-146, CJRSX1600003CN (CJRSX1600003CN); 6375965-146, CJRSX1600004CN (CJRSX1600004CN); 6375965-146, CJRSX1700005CN (CJRSX1700005CN); 6375965-146, CJRSX1700009CN (CJRSX1700009CN); 6375965-100, 00000432220CN2 (CT432220CN2); 6375965-100, 00000438956CN5 (CT438956CN5); 6375965-146, CJRSX1700012CN (CJRSX1700012CN); 6375965-100, 00000438278CN4 (CT438278CN4); 6375965-100, 00000439130CN6 (CT439130CN6); 6375965-146, CJRSX1700003CN (CJRSX1700003CN); 6375965-100, 00000433540CN2 (CT433540CN2); 6375965-100, 00000440700CN3 (CT440700CN3); 6375965-100, 00000441516CN2 (CT441516CN2); 6375965-100, 00000431824CN2 (CT431824CN2); 6375965-146, CJRSX1700004CN (CJRSX1700004CN); 6375965-100, 00000426748CN0 (CT426748CN0); 6375965-100, 00000435884CN2 (CT435884CN2); 6375965-146, CJRSX1600002CN (CJRSX1600002CN); 6375965-100, 00000440598CN1 (CT440598CN1); 6375965-146, 00000443895CN8 (CT443895CN8); 6375965-100, 00000438072CN1 (CT438072CN1); 6375965-100, 00000438426CN9 (CT438426CN9); 6375965-100, 00000441729CN1 (CT441729CN1); 6375965-100, 00000439438CN3 (CT439438CN3); 6375965-100, 00000437682CN8 (CT437682CN8); 6375965-100, 00000441405CN8 (CT441405CN8); 6375965-100, 00000426912CN2 (CT426912CN2); 6375965-100, 00000441984CN2 (CT441984CN2); 6375965-100, 00000432339CN0 (CT432339CN0); 6375965-100, 00000433108CN8 (CT433108CN8); 6375965-146, CJRSX1500002CN (CJRSX1500002CN); 6375965-100, 00000431520CN6 (CT431520CN6); 6375965-100, 00000440381CN2 (CT440381CN2); 6375965-100, 00000426771CN2 (CT426771CN2); 6375965-100, 00000437987CN1 (CT437987CN1); 6375965-146, CJRSX1600006CN (CJRSX1600006CN); 6375965-100, 00000435820CN6 (CT435820CN6); 6375965-100, 00000437399CN9 (CT437399CN9); 6375965-100, 00000439050CN6 (CT439050CN6); 6375965-100, 00000439437CN5 (CT439437CN5); 6375965-100, 00000439974CN7 (CT439974CN7); 6375965-100, 00000439998CN6 (CT439998CN6); 6375965-146, CJRSX1500001CN (CJRSX1500001CN); 6375965-146, CJRSX1700011CN (CJRSX1700011CN); 6375965-100, 00000432173CN3 (CT432173CN3); 6375965-203, 00000306435HM9 (RU2116CT02); 6375965-6 , RSGNA1700007YC (RU4417CT01); 6375965-203, 00000314586HM9 (RU2117CT02); 6375965-203, 00000305388HM1 (RU1084CT02); 6375965-6 , RSGNA1700004YC (RU0191CT01); 6375965-203, 00000342945HM3 (RU7346CT01); 6375965-203, 00000342946HM1 (RU7635CT01); 6375965-203, 00000366681HM5 (RU1254CT03); 6375965-203, 00000385668HM9 (RU2609CT01); 6375965-203, 00000387806HM3 (RU9059CT01); 6375965-6 , RSGNA1700003YC (RU1581CT01); 6375965-6 , RSGNA1700008YC (RU1928CT01); 6375965-6 , 00000069003YC2 (RU8267CT01); 6375965-6 , 00000077301YC0 (RU1107CT02); 6375965-6 , 00000077302YC8 (RU1107CT03); 6375965-203, 00000314588HM5 (RU8157CT01); 6375965-203, 00000342947HM9 (RU8541CT01); 6375965-203, 00000345240HM6 (RU7230CT01); 6375965-203, 00000345242HM2 (RU1192CT01); 6375965-203, 00000381716HM0 (RU8902CT01); 6375965-203, 00000383117HM9 (RU1646CT02); 6375965-203, 00000386889HM0 (RU6973CT01); 6375965-203, 00000388481HM4 (RU9000CT01); 6375965-203, 00000388482HM2 (RU1087CT06); 6375965-203, 00000400972HM6 (RU9564CT01); 6375965-203, 00000405584HM4 (RU1089CT08); 6375965-203, 00000415736HM8 (RU0100CT01); 6375965-203, 00000381717HM8 (RU4574CT01); 6375965-6 , RSGNA1700005YC (RU3138CT03); 6375965-203, 00000345239HM8 (RU3828CT02); 6375965-203, 00000345241HM4 (RU1669CT01); 6375965-203, 00000366680HM7 (RU3720CT01); 6375965-203, 00000385667HM1 (RU1663CT01); 6375965-203, 00000314587HM7 (RU5618CT01); 6375965-6 , RSGNA1700001YC (RU2221CT01); 6375965-6 , RSGNA1800002YC (RU2641CT02); 6375965-203, 00000381714HM5 (RU4573CT01); 6375965-203, 00000386888HM2 (RU1012CT02); 6375965-6 , RSGNA1800001YC (RU1332CT02); 6375965-203, 00000381715HM2 (RU8917CT01); 6375965-6 , RSGNA1800003YC (RU9595CT01); 6375965-6 , RSGNA1700011YC (RU3067CT02); 6375965-203, 00000386523HM5 (RU1786CT03); Model 6375965-123
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