Reported Aug 29, 2018 · Terminated
GE Healthcare Revolution EVO, Optima CT660, Optima CT670, Optima CT680. The systems are intended for head, whole body,…
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
Is this the product you have?
- GE Healthcare Revolution EVO, Optima CT660, Optima CT670, Optima CT680. The systems are intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications
- Sold under the following product names
117 of 117 codes
CT GOLDSEAL LIGHTSPEED ULTRACT OPTIMA 660CT OPTIMA 660 M40 3.5 LONG BJGCT OPTIMA 660 M40 GT1700CT OPTIMA 660 M40 GT1700 BEIJICT OPTIMA 660 M40 GT1700 HINOCT OPTIMA 660 M40 GT2000 BEIJICT OPTIMA 660 M40 GT2000 HINOCT OPTIMA CT 660CT OPTIMA CT660CT OPTIMA CT660 M4CT OPTIMA CT660 M40CT REVOLUTION EVO 3.5 LONG HINCT REVOLUTION EVO VT2000 HINOCT660 MAR UPGRADEMOBILE OPTIMA CT 660OPTI660_A_G_2.0OPTI660_M40_GOPTI660_M40_LOPTIMA 660OPTIMA 660 128 FOR TW- DIRECTOPTIMA 660 GT2000 M40 HINO MULTISLICEOPTIMA 660 M40OPTIMA 660 M40OPTIMA 660 M40 3.5 HVY BJGOPTIMA 660 M40 3.5 LONG BJGOPTIMA 660 M40 3.5 LONG BJGOPTIMA 660 M40 3.5 LONG HINOOPTIMA 660 M40 3.5 MIDOPTIMA 660 M40 3.5 MID BJGOPTIMA 660 M40 3.5 MID HINOOPTIMA 660 M40 3.5/6OPTIMA 660 M40 3.5/6 HVY BJGOPTIMA 660 M40 3.5/6 HVY HINOOPTIMA 660 M40 3.5/6 HVY WAUKOPTIMA 660 M40 3.5/6 LONGOPTIMA 660 M40 3.5/6 LONG BOPTIMA 660 M40 3.5/6 LONG BJGOPTIMA 660 M40 3.5/6 LONG HINOOPTIMA 660 M40 3.5/6 LONG WAUKOPTIMA 660 M40 3.5/6 MID BJOPTIMA 660 M40 3.5/6 MID BJGOPTIMA 660 M40 3.5/6 MID HIOPTIMA 660 M40 3.5/6 MID HINOOPTIMA 660 M40 3.5/6 MID WAOPTIMA 660 M40 3.5/6 MID WAUKOPTIMA 660 M40 GT1700OPTIMA 660 M40 GT1700 BEIJINGOPTIMA 660 M40 GT1700 HINOOPTIMA 660 M40 GT1700 WAUKOPTIMA 660 M40 GT2000 BOPTIMA 660 M40 GT2000 BEIJIOPTIMA 660 M40 GT2000 BEIJINGOPTIMA 660 M40 GT2000 HINOOPTIMA 660 M40 GT2000 WAUKOPTIMA 660 M40 MOBILE BEIJINGOPTIMA CT 660OPTIMA CT660 ASIROPTIMA CT660 ASIR 128 M RUOPTIMA CT660 FREEDOM MD HN2
- Lot codes and dates
- Model Number
- Serial Number (System ID)
1,618 of 1,618 codes
5454001-260CBCGG1600028HM (817261ULTRA)5454001-24000000389996HM0 (83021861077017)5454001-4000000074499YC5 (850210882)5454001-4000000075588YC4 (850210905)5454001-4000000069668YC2 (850210888)5454001-4000000075080YC2 (850210904)5454001-4000000071456YC8 (850210894)5454001-4000000077687YC2 (850210910)5454001-4000000073633YC0 (850210902)5454001-4000000073638YC9 (850210900)5454001-4040GAN1600013YC (850210908)5454001-24000000424383HM8 (HU1113CT01)5454001-24000000391751HM5 (DPN26338)5454001-24000000387390HM8 (UE535A128)5454001-24000000394185HM3 (NEV44709)5454001-24000000394592HM0 (NEV44708)5454001-24000000395002HM9 (NPV79344)5454001-24000000415694HM9 (EP223318)5454001-24000000414003HM4 (CS1346CT01)5454001-24000000411639HM8 (CS1046CT01)5454001-24000000385138HM3 (CS1335CT01)5454001-24000000387391HM6 (H2021CT15)5454001-24000000394590HM4 (H2049CT10)5454001-24000000404914HM4 (H2016CT21)5454001-24000000391756HM4 (H2017CT11)5454001-24000000403534HM1 (HU1015CT03)5454001-24000000411637HM2 (HU1158CT02)5454001-24000000405579HM4 (RO1098CT02)5454001-24000000405574HM5 (RO1303CT01)5454001-4000000066732YC9 (RO1188CT01)
- Amount recalled
- 4,007 devices total (products 1, 2, 3)
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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