Reported Aug 29, 2018 · Terminated

GE Healthcare Optima CT660. 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 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

Lot codes and dates: Model Number
Serial Number (System ID)
185 of 185 codes
6375965-146
CJRSX1600007CN (CJRSX1600007CN)
6375965-146
CJRSX1600001CN (CJRSX1600001CN)
6375965-100
00000433543CN6 (CT433543CN6)
6375965-100
00000438341CN0 (CT438341CN0)
6375965-146
CJRSX1600003CN (CJRSX1600003CN)
6375965-146
CJRSX1600004CN (CJRSX1600004CN)
6375965-146
CJRSX1700005CN (CJRSX1700005CN)
6375965-146
CJRSX1700009CN (CJRSX1700009CN)
6375965-100
00000432220CN2 (CT432220CN2)
6375965-100
00000438956CN5 (CT438956CN5)
6375965-146
CJRSX1700012CN (CJRSX1700012CN)
6375965-100
00000438278CN4 (CT438278CN4)
6375965-100
00000439130CN6 (CT439130CN6)
6375965-146
CJRSX1700003CN (CJRSX1700003CN)
6375965-100
00000433540CN2 (CT433540CN2)
6375965-100
00000440700CN3 (CT440700CN3)
6375965-100
00000441516CN2 (CT441516CN2)
6375965-100
00000431824CN2 (CT431824CN2)
6375965-146
CJRSX1700004CN (CJRSX1700004CN)
6375965-100
00000426748CN0 (CT426748CN0)
6375965-100
00000435884CN2 (CT435884CN2)
6375965-146
CJRSX1600002CN (CJRSX1600002CN)
6375965-100
00000440598CN1 (CT440598CN1)
6375965-146
00000443895CN8 (CT443895CN8)
6375965-100
00000438072CN1 (CT438072CN1)
6375965-100
00000438426CN9 (CT438426CN9)
6375965-100
00000441729CN1 (CT441729CN1)
6375965-100
00000439438CN3 (CT439438CN3)
6375965-100
00000437682CN8 (CT437682CN8)
6375965-100
00000441405CN8 (CT441405CN8)
Amount recalled: 92 OUS only

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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