GE Healthcare Japan Corporation: 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

Recall number

Z-2873-2018

Recalling firm

GE Healthcare Japan Corporation

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

Status

Terminated

Initiated

2018-04-27

Posted

not on file

Terminated

2020-08-21

Reason

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

Root cause

Employee error

Action

The firm, GE Healthcare, sent an " URGENT MEDICAL DEVICE CORRECTION" letter dated 4/27/2018 to its Customers on about 04/27/2018. The letter describes the product, problem and actions to be taken. The customers were Instructed to: download and provide the updated Service Manual to the organization that services the equipment on site and informed customers that GE Healthcare would be correcting all affected devices at no cost. Questions or concerns can be directed to GE Healthcare Service at 1-800-437-1171 or the local Sales Representative. GE Healthcare expanded the recall to include an additional product and model number. Customers were notified on about 08/09/2018 via URGENT MEDICAL DEVICE CORRECTION letter. Instructions were the same as the original notification.

Quantity

92 OUS only

Distribution

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.

Lot, serial or model codes

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

510(k) numbers

["K082816","K110227","K131576"]

PMA numbers

not on file

Product code

JAK

Firm FEI

3002808529

Firm city

Hino

Firm state

Asahigaoka

Firm country

Japan

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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