CLASS II Device recall · Reported 29 Aug 2018 · FDA Enforcement Report
GE Healthcare Optima CT660 recalled
GE Healthcare Japan is recalling GE Healthcare Optima CT660, distributed nationwide in the US. The recall was initiated on 27 Apr 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2873-2018
- FDA event ID
- 80563
- Recalling firm
- GE Healthcare Japan, Hino
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Apr 2018
- FDA classified
- 17 Aug 2018
- Reported
- 29 Aug 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 27 Apr 2018 | Recall initiated by company | |
| 17 Aug 2018 | Classified by FDA | +112 days |
| 29 Aug 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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
Where it was distributed
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.
Nationwide AlaskaAlabamaCaliforniaColoradoConnecticutDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMarylandMaineMichiganMinnesota
Questions about this recall
Is GE Healthcare Optima CT660 recalled?
Yes. GE Healthcare Japan recalled GE Healthcare Optima CT660 on 27 Apr 2018. The recall is Class II and its status is Terminated. Recall number Z-2873-2018.
Why was it recalled?
GE Healthcare has identified that some CT systems may have a damaged cable that can expose 120VAC to Service Engineers working inside the gantry.
Which lots are affected?
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
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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