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U.S. Department of Health and Human Services

Class 2 Device Recall GE Healthcare Optima CT660

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  Class 2 Device Recall GE Healthcare Optima CT660 see related information
Date Initiated by Firm April 27, 2018
Create Date August 17, 2018
Recall Status1 Terminated 3 on August 21, 2020
Recall Number Z-2873-2018
Recall Event ID 80563
510(K)Number K131576  K110227  K082816  
Product Classification System, x-ray, tomography, computed - Product Code JAK
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
Code Information 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  
Recalling Firm/
Manufacturer		 GE Healthcare Japan Corporation
Ge Herusukea.Japan ( Kabu -4 Chome 7-127
Asahigaoka
Hino Japan
For Additional Information Contact
800-437-1171
Manufacturer Reason
for Recall		 GE Healthcare has identified that some CT systems may have a damaged cable that can expose 120VAC to Service Engineers working inside the gantry.
FDA Determined
Cause 2		 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 in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JAK and Original Applicant = GE MEDICAL SYSTEMS, LLC
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