Reported Aug 29, 2018 · Terminated

GE Healthcare Optima CT540. The systems are intended for head, whole body, cardiac and vascular X-ray Computed…

GE Healthcare Japan Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: GE Healthcare Japan Corporation · Ge Herusukea.Japan ( Kabu -4 Chome 7-127 · Hino · N/A

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 namesBEIJING 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

Lot codes and dates: Model Number
Serial Number (System ID)
1,086 of 1,086 codes
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 (713461MMCT)
5432539
00000339269HM3 (571367OP540)
5432539
00000359124HM5 (304526OPT540)
5432539
00000341572HM6 (DZ1547CT01)
5432539
00000394557HM3 (DZ1728CT01)
5432539-3
CBAQG1500007HM (DZ1865CT01)
Amount recalled: 4,007 devices total (products 1, 2, 3)

The agency filed one notice per product. You are reading one of them; the other 3 are below.

GE Healthcare has identified that some CT systems may have a damaged cable that can expose 120VAC to Service Engineers working inside the gantry.

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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