GE Healthcare Japan Corporation: Medical Device Recall in 2018 - (Recall #: Z-2873-2018)

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

Class II

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

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

Worldwide Distribution: US (Nationwide) distribution to states of: AK, AL, CA, CO, CT, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, RI, SC, SD, TN, TX, UT, WI, WV, WY; and countries of:: ALGERIA, ARGENTINA, ARMENIA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BOLIVIA, BOSNIA AND HERZEGOVINA, BRAZIL, BULGARIA, CAMEROON, Canada, CHILE, CHINA, COLOMBIA, Cote D'Ivoire, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, ETHIOPIA, FINLAND, FRANCE, French Guiana, GERMANY, GHANA, GREECE, GUADELOUPE, GUATEMALA, HONDURAS, Hong Kong, HUNGARY, INDIA, INDONESIA, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN, Korea (Republic of), KUWAIT, LATVIA, LEBANON, LIBYA, LITHUANIA, MALAYSIA, Mali, MALTA, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW , ZEALAND, NIGERIA, NORWAY, OMAN, PAKISTAN, Palestine, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, REUNION, ROMANIA, Russia, RWANDA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TANZANIA, THAILAND, TUNISIA, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, UZBEKISTAN, VENEZUELA, VIETNAM, and YEMEN.

Voluntary: Firm initiated