Reported Jun 15, 2016 · Terminated
GE Revolution CT The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography…
GE Healthcare, LLC
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, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- GE Revolution CT The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles.
- Lot codes and dates
- Mfg Lot or Serial # System ID 00000437624CN0 N/A 00000439694CN1 N/A 00000439777CN4 N/A 00000439930CN9 N/A 00000441224CN3 203688ERREV1 00000441575CN8 N/A 00000441624CN4 N/A 00000441648CN3 N/A 00000441916CN4 469841REVO 00000442032CN9 N/A 00000442124CN4 N/A 00000442219CN2 N/A 00000442443CN8 N/A 00000443993CN1 N/A 00000444530CN0 N/A 00000445085CN4 N/ARMHCTREV
00000438756CN9309655REVCT00000439113CN2212241REVCT00000439205CN6415476MCT300000439287CN4415476MCT200000439836CN8215662CTREV00000440713CN6815226RVCT00000441459CN5206320REV00000441716CN8808522RCT00000442228CN3281274REV00000442994CN0919684REVCT00000443379CN3608263REVCT00000443664CN8409772CT700000443900CN6402481BEREVCT00000444165CN5AM14CFI6500000444175CN4801507REV00000444253CN9704384REV00000444745CN4808KMCCT00000444872CN6316268REVCT00000445059CN9310222REVO438369CN1206598REV1438902CN9801662REV1439823CN6408356RV1439835CN0503216SREV441040cn3215952CTREV441064CN3256HHRCT1441066CN8414805REVCT441262CN3
N/A441990CN9206598ERREV442592CN2205699CTREV442706CN8727398REVO443069CN0404616CTR443227CN4940898REVO443327CN2858824REVCT444398CN2731541REVCT444409CN7386REVCT3444840CN3760940REVCT444913CN8206288SCREV00000437624CN0786596WKRIVO00000439777CN4703698REVOCT00000439930CN9715847RCT100000442124CN4408498RV2443327CN2858824REVCT00000441624CN4217876REVO100000445085CN4713792ACT3500000441575CN8847437ACT7442032CN9512DELLCT00000442994CN0
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
N/A 00000444470CN9 82421040372 00000444648CN0 82421100836 00000444706CN6 N/A 00000444712CN4 82421100835 00000444888CN2 82421100846 00000444926CN0 N/A 00000444969CN0 N/A 00000445019CN3 82421130179 00000445199CN3 N/A442219CN2416284CT1442443CN8604682RCT100000440672CN48242104035000000440940CN58242104034500000440986CN88242105010600000441519CN68242104034600000441805CN98242104035900000441899CN28242112047900000442052CN78242103019900000442479CN28242119032400000442749CN88242104036900000443071CN68242130007200000443167CN28242119031700000443253CN08242112048400000443308CN28242104037000000443741CN48242120026600000444092CN18242112052400000444206CN78242116042500000444243CN08242115016700000444317CN2
N/A 00000442622CN7 850210885 00000442940CN3 850210884 00000443590CN5 850210890 00000445179CN5 N/A71 of 71 codes
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
N/A00000441549CN3KW1098CT0100000442802CN5KW1011CT0300000444791CN8KW1011CT0400000444110CN1CT444110CN0100000439632CN18510990918500000442289CN5NO1031CT0100000442868CN6NO1146CT0200000445041CN7
N/A 00000444345CN3 N/A00000442748CN0CT442748CN000000444156CN4CT444156CN400000439834CN3PL1008CT0400000440221CN0PL1150CT0300000440441CN4SA1012CT1000000443703CN4
N/A00000444375CN0SA1012CT1200000443956CN86073CT001300000443448CN6DPN8863800000444082CN2MPX3011400000439660CN2D007CT0700000440739CN1A010CT1600000441292CN0A010CT1700000443380CN1A201CT0200000443400CN7A201CT0100000443540CN0A201CT0300000443952CN7R002CT0900000444016CN0A007CT0400000444672CN0
00000438438CN4900010CT0600000439169CN4260010CT1900000443556CN6260010CT2000000442350CN585321029200000438994CN6AE1477CT0100000444038CN4AE1015CT02DUMFMI25465B0100216CTS1300000440706CN000160CTS0300000440906CN600487CTS0300000440928CN000243CTS1100000443409CN800145CTS0100000443994CN900095CTS04
- Mfg Lot or Serial # System ID 00000437624CN0 N/A 00000439694CN1 N/A 00000439777CN4 N/A 00000439930CN9 N/A 00000441224CN3 203688ERREV1 00000441575CN8 N/A 00000441624CN4 N/A 00000441648CN3 N/A 00000441916CN4 469841REVO 00000442032CN9 N/A 00000442124CN4 N/A 00000442219CN2 N/A 00000442443CN8 N/A 00000443993CN1 N/A 00000444530CN0 N/A 00000445085CN4 N/A
- Amount recalled
- 197 (US = 68; OUS = 129)
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
GEHC has become aware of a potential safety issue in the Revolution CT Patient Table that can result in unintended motion in cases involving large patients. The Revolution CT cradle can descend on its own after activation by the user. This can put the patient at risk for harm. The harm can involve the impinging or crushing of a hand if caught between the cradle and CT inner gantry bore. No injurie
This product could cause temporary or reversible health problems — stop using it.
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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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