GE Healthcare Optima CT660. The systems are intended for head, whole body, cardiac and vascular ...
FDA Device Recall #Z-2873-2018 — Class II — April 27, 2018
Recall Summary
| Recall Number | Z-2873-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 27, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | GE Healthcare Japan Corporation |
| Location | Hino |
| Product Type | Devices |
| Quantity | 92 OUS only |
Product 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
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.
Distribution Pattern
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 / 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
Other Recalls from GE Healthcare Japan Corporation
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2871-2018 | Class II | GE Healthcare Optima CT660. Sold under the fol... | Apr 27, 2018 |
| Z-2870-2018 | Class II | GE Healthcare Revolution EVO, Optima CT660, Opt... | Apr 27, 2018 |
| Z-2872-2018 | Class II | GE Healthcare Optima CT540. The systems are in... | Apr 27, 2018 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.