GE Healthcare Optima CT540 — Class II medical device recall Z-2872-2018
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-2872-2018 |
|---|---|
| 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 |
| UPC / GTIN / UDI-DI | 00082421290130, 83016600022314, 83021600015914, 83021602972314, 83021606244714 |
| Serial numbers | 00000406425HM9, 00000409871HM1, 5432539, 5432539-2 |
Product
GE Healthcare Optima CT540. The systems are intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.Sold under the following product names: BEIJING CT OPTIMA 540, BEIJING OPTIMA, BEIJING OPTIMA 540, BEIJING OPTIMA 540 ASIR, CT BEIJING OPTIMA 540, CT BEIJING OPTIMA 540 ASIR, CT GOLDSEAL OPTIMA 540, CT OPTIMA 540, CT OPTIMA 540 ASIR, CT OPTIMA CT540 TANG BEIJING, DISCOVERY 670 3/8 MEA PRO, HINO OPTIMA 540, HINO OPTIMA 540 ASIR, HINO OPTIMA 540 ASIR, OPTIMA 540, OPTIMA 540 ASIR, OPTIMA 540 MOBILE BEIJING, OPTIMA CT540, OPTIMA CT540 32 SLICES, OPTIMA CT540 ASIR, OPTIMA CT540 BJG SKD RUSSIA, Optima CT540 Gantry Top Asm with Rating Plate,SGB tube and CJ cover, Optima CT540 Gantry Top Asm with Rating Plate,SGB tube and CJ cover for Hino, OPTIMA CT540 TANG, OPTIMA CT540 TANG BEIJING, OPTIMA CT540 TANG HINO
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-2872-2018. 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.