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 I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- GE Healthcare Japan Corporation
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2873-2018
Related Recalls
GE Healthcare has identified that some CT systems may have a damaged cable that can expose 120VAC to Service Engineers working inside the gantry.
GE Healthcare has identified that some CT systems may have a damaged cable that can expose 120VAC to Service Engineers working inside the gantry.
GE Healthcare has identified that some CT systems may have a damaged cable that can expose 120VAC to Service Engineers working inside the gantry.