FDA Device recall Z-2872-2018
GE Healthcare Optima CT540
- FDA Device
- Class II
- terminated
- Published 2018-08-29
On 2018-08-29 the FDA classified a Class II recall of GE Healthcare Optima CT540 by Ge Healthcare Japan, citing GE Healthcare has identified that some CT systems may have a damaged cable that can expose 120VAC to Service Engineers working inside the gantry.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2872-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-04-27 |
| Published | 2018-08-29 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ge Healthcare Japan |
| Distribution | US |
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
GE Healthcare has identified that some CT systems may have a damaged cable that can expose 120VAC to Service Engineers working inside the gantry.
Identifiers
| code_info | Model Number, Serial Number (System ID): 5432539, 00000409871HM1 (IR1304CT02); 5432539, 00000406425HM9 (IR1563CT…Model Number, Serial Number (System ID): 5432539, 00000409871HM1 (IR1304CT02); 5432539, 00000406425HM9 (IR1563CT01); 5432539-2, Not Available (970GMCT1); 5432539-2, 343769HM6 (262434OPTCT1); 5432539, 383019HM7 (251809DWMCT); 5432539-2, 00000058405YC2 (928289CT); 5432539, 00000340698HM0 (TMCACT540); 5432539, 340698HM0 (AM16OG71165); 5432539, 377682HM0 (850314CT); 5432539, 00000333256HM6 (954916OPT16); 5432539, 00000350436HM2 (912466OCT); 5432539, 00000354310HM5 (770382ERCT); 5432539, 00000361670HM3 (919956CT); 5432539, 00000370798HM1 (704403KAN); 5432539, 00000358402HM6 (910642CT2); 5432539, 00000348412HM8 (SJRCT540); 5432539, Not Available (631367OPTMA); 5432539, 00000350435HM4 (803632CT16); 5432539, 00000377063HM3 (901516SCT2); 5432539, 00000353930HM1 (214276CT); 5432539, 00000358081HM8 (806592OPT); 5432539, 00000339268HM5 (817465PORT); 5432539, 397568HM7 (713MMRINWCT); 5432539, 00000348790HM7 (281949CF04); 5432539, 00000369111HM0 ( |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2872-2018%22
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