GE Healthcare Optima CT660 — Class II medical device recall Z-2873-2018
Terminated recall by GE Healthcare Japan Corporation, reported 2018-08-29, distributed nationwide. GE Healthcare has identified that some CT systems may have a damaged cable that can expose 120VAC to Service E
| Recall number | Z-2873-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare Japan Corporation, Hino, Japan |
| Recall initiated | 2018-04-27 |
| Classified | 2018-08-17 |
| Reported by FDA | 2018-08-29 |
| Terminated | 2020-08-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BH, BO, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DZ, EC, EG, ES, FI, FR, GB, GH, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IQ, IR, IT, JO, JP, KR, KW, LB, LT, LV, MA, MT, MX, MY, NG, NL, NO, OM, PA, PE, PH, PK, PL, PT, RO, RU, SA, SE, SG, SI, SK, TH, TN, TR, TW, UA, UY, VE, VN, ZA |
| Quantity | 92 ous |
| Serial numbers | 00000069003YC2, 00000077301YC0, 00000077302YC8, 00000305388HM1, 00000306435HM9, 00000314586HM9, 00000314587HM7, 00000314588HM5, 00000342945HM3, 00000342946HM1, 00000342947HM9, 00000345239HM8, 00000345240HM6, 00000345241HM4, 00000345242HM2, 00000366680HM7, 00000366681HM5, 00000381714HM5, 00000381715HM2, 00000381716HM0, 00000381717HM8, 00000383117HM9, 00000385667HM1, 00000385668HM9, 00000386523HM5 and 71 more |
| Model numbers | 6375965-123 |
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2873-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.