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U.S. Department of Health and Human Services

Class 2 Device Recall Revolution CT, Revolution CT ES

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Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


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 Class 2 Device Recall Revolution CT, Revolution CT ESsee related information
Date Initiated by FirmDecember 17, 2020
Create DateFebruary 17, 2021
Recall Status1 Terminated 3 on January 09, 2023
Recall NumberZ-1130-2021
Recall Event ID 87089
510(K)NumberK133705 K163213 K191777 
Product Classification System, x-ray, tomography, computed - Product Code JAK
ProductSystem, X-Ray, Tomography, Computed: Revolution CT, Revolution CT ES.
Code Information Model Numbers:  5590000: 00000441224CN3, 00000441064CN3, 00000442592CN2, 00000396676HP9, 00000442124CN4, 00000439287CN4, 00000439205CN6, 00000439823CN6, 00000445059CN9, 00000442706CN8, 00000444409CN7, 00000437624CN0, 00000443069CN0, 00000444745CN4, 00000441716CN8, 00000441624CN4, 00000441575CN8, 00000445084CN7, 00000444165CN5, 00000444872CN6, 00000443900CN6, 00000441262CN3, 00000439835CN0, 00000441040CN3, 00000439836CN8, 00000444398CN2, 00000442032CN9, 000003993CN1, 00000443227CN4, 00000443664CN8, 00000442228CN3, 00000445085CN4, 00000441916CN4, 00000444175CN4, 00000438902CN9, 00000439777CN4, 00000444913CN8, 00000441459CN5, 00000443379CN3, 00000441066CN8, 00000436942CN7, 00000442968CN4, 00000441694CN7, 00000439799CN8, 00000441381CN1, 00000441578CN2, 00000439505CN9, 00000440315CN0, 00000443038CN5, 00000441683CN0, 00000442044CN4, 00000442094CN9, 00000442443CN8, 00000443342CN1, 00000437410CN4, 00000440051CN1, 00000442219CN2, 00000442378CN6, 00000442163CN2, 00000441839CN8, 00000442412CN3, 00000444278CN6, 00000442507CN0, 00000442256CN4, 00000442792CN8, 00000441105CN4, 00000441768CN9, 00000436925CN2, 00000440136CN0, 00000439368CN2, 00000443675CN4, 00000441210CN2, 00000438247CN9, 00000440778CN9, 00000440478CN6, 00000443869CN3, 00000443471CN8, 00000441177CN3, 00000439537CN2, 00000443501CN2, 00000442785CN2, 00000440622CN9, 00000441322CN5, 00000439407CN8, 00000439754CN3, 00000439931CN7, 00000437849CN3, 00000439234CN6, 00000441959CN4, 00000442334CN9, 00000444523CN5, 00000443590CN5, 00000442622CN7, 00000442940CN3, 00000441549CN3, 00000444110CN1, 00000439632CN1, 00000442868CN6, 00000445041CN7, 00000442289CN5, 00000444156CN4, 00000442748CN0, 00000439834CN3, 00000440221CN0, DUMFMI25476002, 00000443703CN4, 00000440441CN4, 00000444375CN0, 00000444345CN3, 00000443956CN8, 00000444082CN2, 00000443448CN6, 00000439660CN2, 443952CN7, 00000444672CN0, 00000443400CN7, 00000443380CN1, 00000443540CN0, 00000444016CN0, 00000441292CN0, 439169CN4, 00000438438CN4, 00000442350CN5, 00000438994CN6, 00000444038CN4, 00000443409CN8, 00000443994CN9, 00000440906CN6, 00000440928CN0, 00000440706CN0, 00000442887CN6   5590000-2: REVCX1600026CN, REVCX1700012CN, REVCX1700025CN, 00000444706CN6, 00000444648CN0, REVCX1600017CN, REVCX1600023CN, REVCX1600005CN, REVCX1600018CN, REVCX1600019CN, REVCX1700010CN, REVCX1600011CN, 00000445258CN7, REVCX1700004CN, REVCX1700013CN, REVCX1700023CN, REVCX1700028CN, REVCX1600006CN, 00000442052CN7, REVCX1700008CN, REVCX1600004CN, REVCX1700014CN, REVCX1700022CN, REVCX1700027CN, REVCX1600012CN, REVCX1600022CN, REVCX1600025CN, REVCX1700026CN, REVCX1700011CN, REVCX1700003CN, REVCX1700017CN, REVCX1600014CN, REVCX1700024CN, REVCX1600003CN, REVCX1700018CN, REVCX1700015CN, 00000445348CN6, 00000444470CN9, 00000443308CN2, 00000442749CN8, 00000440672CN4, 00000440940CN5, 00000444969CN0, 00000441805CN9, 00000441519CN6, 00000443167CN2, 00000445391CN6, REVCX1700002CN, 00000444243CN0, 00000443741CN4, 00000444888CN2, REVCX1600001CN, REVCX1600027CN, REVCX1700007CN, 00000445019CN3, 00000444947CN6, 00000444206CN7, 00000445199CN3, 00000444317CN2, 00000445326CN2, 00000440986CN8, 00000442479CN2, 00000445459CN1, 00000443253CN0, 00000441899CN2, 00000443071CN6, 00000444712CN4, 00000444092CN1, 00000445239CN7, 00000445438CN5, REVCX1700009CN, REVCX1600009CN, REVCX1600015CN, REVCX1700005CN, 00000444926CN0, REVCX1600007CN, REVCX1700001CN, REVCX1600020CN, REVCX1700006CN, REVCX1600010CN, REVCX1700020CN, REVCX1700016CN, REVCX1700019CN, REVCX1600008CN, REVCX1600016CN, REVCX1600024CN, REVCX1700021CN, REVCX1600013CN, REVCX1600002CN, REVCX1600021CN   5595000-6: REVVX1900055CN, REVVX1900057CN, REVVX1900056CN, REVVX1900065CN, REVVX1900063CN, REVVX1900016CN, REVVX1900066CN, REVVX1900064CN, REVVX1900062CN   5595000-7: REVCV1900017CN, REVCV1900015CN, REVCV1900018CN, REVCV1900011CN, REVCV1900010CN  5590000-6: REVVX1700033CN, REVVX1700097CN, REVVX1900093CN, REVVX2000059CN, REVVX1800107CN, REVVX1900113CN, REVVX1600034CN, REVVX2000057CN, REVVX1700018CN, REVVX1900036CN, REVVX1900035CN, REVVX2000037CN, REVVX2000027CN, REVVX1800033CN, REVVX1800050CN, REVVX1700077CN, REVVX1800051CN, REVVX1900023CN, REVVX1600058CN, REVVX1800025CN, REVVX2000008CN, REVVX1800063CN, REVVX2000055CN, REVVX1600005CN, REVVX1700027CN, REVVX1900007CN, REVVX2000028CN, REVVX1800093CN, REVVX1900067CN, REVVX1800091CN, REVVX1700044CN, REVVX1900027CN, REVVX1800086CN, REVVX2000025CN, REVVX1900072CN, REVVX1600038CN, REVVX1700091CN, REVVX2000001CN, REVVX1700120CN, 00000444970CN8, REVVX1800053CN, REVVX1700083CN, REVVX1800021CN, REVVX1800043CN, REVVX1600039CN, REVVX1700067CN, REVVX1800007CN, REVVX1900101CN, REVVX2000054CN, REVVX1800057CN, REVVX1700007CN, REVVX1600018CN, REVVX1700090CN, REVVX1600016CN, REVVX1900073CN, REVVX1800105CN, REVVX1800048CN, REVVX1900123CN, REVVX1600023CN, REVVX1700093CN, REVVX1800005CN, REVVX1800004CN, REVVX1800046CN, REVVX1800037CN, REVVX1800096CN, REVVX1900092CN, REVVX1700059CN, REVVX2000005CN, REVVX2000018CN, REVVX1800071CN, REVVX1700113CN, REVVX1900011CN, REVVX2000053CN, REVVX1700062CN, 00000445119CN1, REVVX1700022CN, REVVX1700026CN, REVVX1600024CN, REVVX1900120CN, REVVX1700015CN, REVVX1600010CN, REVVX1800132CN, REVVX1600032CN, REVVX1900033CN, REVVX1900082CN, REVVX1600013CN, REVVX1700101CN, REVVX1900069CN, REVVX1700061CN, REVVX1800126CN, REVVX1700047CN, REVVX1700107CN, REVVX1800076CN, REVVX1800080CN, REVVX1800058CN, REVVX1800054CN, REVVX2000039CN, REVVX1900105CN, REVVX1700029CN, REVVX1700079CN, REVVX1700065CN, REVVX1700089CN, REVVX2000034CN, REVVX1900058CN, REVVX1600052CN, REVVX1700088CN, REVVX2000047CN, REVVX1800123CN, REVVX1600002CN, REVCV1900020CN, 00000445397CN3, REVVX1800108CN, REVVX1800127CN, REVVX1900068CN, REVVX1900115CN, REVVX1900029CN, REVVX1600001CN, REVVX1900070CN, REVVX1900071CN, REVVX1700078CN, REVVX1900008CN, REVVX1900088CN, REVVX1600025CN, REVVX1800059CN, REVVX1900107CN, REVVX1900003CN, REVVX1800124CN, REVVX1900100CN, REVVX1900078CN, REVVX1800089CN, REVVX1700019CN, REVVX1600029CN, REVVX1800047CN, REVVX1800119CN, REVVX1800090CN, REVVX1600020CN, REVVX1700085CN, REVVX1600048CN, REVVX1700124CN, REVVX1700052CN, REVVX1800092CN, REVVX1900030CN, REVVX1800013CN, REVVX1600059CN, REVVX2000014CN, REVVX1700057CN, REVVX1800115CN, REVVX1800074CN, REVVX1700024CN, REVVX1800079CN, REVVX1900019CN, REVVX1600007CN, REVVX1700069CN, REVVX1800070CN, REVVX1700008CN, REVVX1600011CN, REVVX1600044CN, REVVX1700043CN, REVVX1600014CN, REVVX1800133CN, REVVX2000032CN, REVVX1900049CN, REVVX1700068CN, REVVX1900018CN, REVVX1800099CN, REVVX1900014CN, REVVX1900112CN, REVVX1700064CN, REVVX1700006CN, REVVX1800017CN, REVVX1700017CN, REVVX1800028CN, REVVX1800009CN, REVVX1700028CN, REVVX1700041CN, REVVX1800104CN, REVVX1800066CN, REVVX2000010CN, REVVX1600015CN, REVVX1900034CN, REVVX1900098CN, 00000445060CN7, REVVX1700031CN, REVVX1600054CN, REVVX1700084CN, REVVX1900124CN, REVVX1900075CN, REVVX1800011CN, REGGL2000013YC, REVVX1800121CN, DUMFMI25490001, REVVX1800087CN, REVVX1800125CN, REVVX1700099CN, REVVX1800095CN, REVVX1800041CN, REVVX1800045CN, REVVX1700054CN, REVVX1800067CN, REVVX1600035CN, REVVX1800055CN, REVVX1800027CN, REVVX1800100CN, REVVX1800111CN, REVVX1900077CN, REVVX2000017CN, REVVX1600012CN, REVVX2000002CN, REVVX1800131CN, REVVX2000063CN, REVVX2000016CN, REVVX1800052CN, REVVX1700076CN, REVVX1600036CN, REVVX1800040CN, REVVX1900090CN, REVVX1600009CN, REVVX1700074CN, REVVX1900041CN, REVVX1700071CN, REVVX1800075CN, REVVX1900048CN, REVVX1700082CN, REVVX2000067CN, REVVX1600046CN, REVVX1600050CN, REVVX1700075CN, REVVX1600008CN, REVVX1900043CN, REVVX1600022CN, REVVX2000061CN, REVVX1700011CN, REVVX1700081CN, REVVX1700070CN, REVVX1700111CN, REVVX1900117CN, REVVX1800001CN, REVVX1800114CN, REVVX1600006CN, REVVX1900095CN, REVVX1700115CN, REVVX1900104CN, REVVX1800020CN, REVVX1600003CN, 00000445345CN2, 00000445249CN6, REVVX1600051CN, REVVX1900109CN, REVVX2000064CN, REVVX1900114CN, REVVX1900037CN, REVVX1800116CN, REVVX1700004CN, REVVX1900047CN, REVVX1900116CN, REVVX2000013CN, REVVX1900025CN, REVVX1700072CN, REVVX1600056CN, REVVX1800031CN, REVVX1700092CN, REGGL1900001YC, REVVX1700126CN, REVVX1800018CN, REVVX1800130CN, REGGL1900007YC, REVVX1700103CN, REVVX1700039CN, REVVX1700001CN, REVVX1700010CN, REVVX1700100CN, REVVX1800118CN, REGGL2000010YC, REVVX1700121CN, REVVX1700119CN, REVVX1800097CN, REGGL1900011YC, REVVX1700016CN, REVVX1800039CN, REVVX1600017CN, REVVX1700012CN, 00000445375CN9, REGGL1900006YC, REVVX1600026CN, REVVX1800065CN, REVVX1800129CN, REGGL1900008YC, REGGL2000004YC, REVVX1700127CN, REVVX1900052CN, REVVX1900021CN, REGGL1900014YC, REGGL2000003YC, REGGL2000002YC, REVVX1800122CN, REVVX1700021CN, REGGL1900004YC, REVVX1700073CN, REVVX1900026CN, REVVX1700025CN, REVVX1900013CN, REVVX1800081CN, REVVX1700105CN, REVVX1900046CN, REVVX1900059CN, REVVX1600027CN, REVVX1600033CN, REVVX1900015CN, REVVX1900009CN, REGGL2000017YC, REGGL2000018YC, REGGL2000019YC, REGGL2000020YC, REGGL2000021YC, REGGL1900015YC, REGGL1900003YC, REVVX1900044CN, REGGL1900013YC, REVVX1800117CN, REVVX1900031CN, REGGL1900005YC, REVVX1600042CN, 00000445429CN4, REVVX1800113CN, 00000445156CN3, REVVX1700058CN, REVVX1900001CN, REGGL2000006YC, REGGL2000001YC, REGGL1900012YC, REVVX1600047CN, REVVX1700020CN, REVVX1700125CN, REVVX1800023CN, REVVX1800068CN, REGGL1900002YC, REVVX1900050CN, REVVX2000019CN, REVVX1800014CN, REGGL2000014YC, REVVX1700013CN, REVVX1900002CN, REVVX1700066CN, REVVX1800044CN, REVVX1600004CN, REVVX1800006CN, REVVX1700005CN, REVVX1700049CN, REVVX1600057CN, 00000445179CN5, REVVX1800109CN, REVVX1800056CN, REVVX2000023CN, REVVX2000041CN, REVVX1900045CN, REVVX1700030CN, REVVX1800049CN, 00000444791CN8, REVVX1600030CN, REVVX1900118CN, REVVX1700034CN, REVVX1800069CN, REVVX1800077CN, REVVX1800012CN, REVVX1700063CN, REVVX1800022CN, REVVX1900010CN, REVVX1900028CN, REVVX1800019CN, REVVX1900074CN, REVVX1700040CN, REVVX1700096CN, REVVX1700038CN, REVVX1800010CN, REVVX1700106CN, REVVX1800073CN, REVVX1800083CN, REVVX1700117CN, REVVX1600043CN, REVVX2000007CN, REVVX2000011CN, REVVX1600045CN, REVVX1800008CN, REVVX1800088CN, REVVX2000006CN, REVVX1700009CN, REVVX1700102CN, REVVX2000068CN, REVVX1900005CN, REVVX1700014CN, REVVX1800078CN, REVVX1700045CN, REVVX1900012CN, REVVX1700110CN, REVVX1800084CN, REVVX1700108CN, REVVX1700035CN, REVVX1700122CN, 00000445280CN1, REVVX1800038CN, REVVX1600031CN, REVVX1800032CN, REVVX1700048CN, REVVX1700053CN, REVVX1700055CN, REVVX1800064CN, REVVX1800072CN, REVVX1800103CN, REVVX2000030CN, REVVX2000050CN, REVVX1600049CN, REVVX1800034CN, REVVX1600021CN, REVVX1600037CN, REVVX1800101CN, REVVX1600041CN, REVVX1700003CN, REVVX2000003CN, REVVX1600062CN, REVVX1900125CN, REVVX1900086CN, REVVX1900102CN, REVVX1900106CN, REVVX1700104CN, REVVX1700116CN, REVVX1700050CN, REVVX1700037CN, REVVX1700086CN, REGGL2000016YC, REVVX1600055CN, REVVX1600040CN, REVVX1900053CN, REVVX1800085CN, REGGL2000009YC, REVVX1800016CN, REGGL2000015YC, REVVX1800036CN, REVVX1900110CN, REVVX1900039CN, REVVX1800082CN, REVVX1600028CN, REVVX1900054CN, REVVX1700098CN, REVVX1900061CN, REVVX1700032CN, REVVX1800035CN, REVVX1700112CN, REVVX1800060CN, 00000445134CN0, REVVX1900091CN, REVVX2000062CN, REVVX1800024CN, REVVX1800062CN, DUMFMI25490004, REVVX1900097CN, REVVX1900079CN, DUMFMI25490005, REVVX1900121CN, REVVX1800094CN, REVVX1700080CN, REVVX1700060CN, REVVX1800029CN, REVVX1700114CN, REVVX1700095CN, REVVX1700109CN, REVVX1700123CN, REVVX1800002CN, REVVX1800106CN, REVVX1600061CN, REVVX1700036CN, REVVX1600053CN, REVVX1900017CN, REVVX1800026CN, REVVX2000015CN, REVVX2000042CN, REGGL2000022YC, REVVX1900103CN, REVVX2000035CN, REVVX2000045CN, REVVX1900087CN   5590000-7: REVVX1900022CN, REVCV1700019CN, REVCV1800033CN, REVCV1800007CN, REVCV1800022CN, REVCV1800088CN, REVCV1800058CN, REVCV1800042CN, REVCV1800025CN, REVCV1800053CN, REVCV1800006CN, REVVX1700087CN, REGCN2000028YC, REVCV1800071CN, REVCV1700003CN, REVCV1800074CN, REVCV1900002CN, REVCV1900001CN, REVCV1700016CN, REVCV1700017CN, REGCN1900010YC, REGCN2000023YC, REGCN1900029YC, REVCV1800024CN, REGCN1900002YC, REVCV1800044CN, REGCN1900006YC, REVCV1800069CN, REGCN2000010YC, REVCV1900008CN, REGCN2000054YC, REGCN1900027YC, REVCV1800018CN, REVCV1800028CN, REGCN2000040YC, REVCV1700020CN, REVCV1800009CN, REVCV1800059CN, REVCV1700014CN, REVCV1800032CN, REVCV1800079CN, REGCN2000057YC, REVCV1700027CN, REVCV1800034CN, REGCN2000018YC, REGCN2000047YC, REVCV1900006CN, REVCV1800019CN, REGCN2000005YC, REGCN2000051YC, REVCV1800082CN, REVCV1800008CN, REVCV1800003CN, REVCV1800072CN, REGCN1900019YC, REVCV1800047CN, REVCV1800029CN, REVCV1800050CN, REGCN1900018YC, REVV81900027CN, REVCV1800046CN, REVCV1800020CN, REVCV1700001CN, REGCN2000020YC, REVCV1800073CN, REVCV1900030CN, REVCV1700015CN, REGCN1900024YC, REVCV1800085CN, REVCV1900003CN, REVCV1800021CN, REGCN1900022YC, REVCV1800051CN, REGCN2000071YC, REGCN1900008YC, REVCV1700005CN, REVCV1800086CN, REVCV1900005CN, REVCV1800014CN, REVCV1800031CN, REGCN2000052YC, REGCN2000011YC, REGCN2000014YC, REVCV1700012CN, REGCN2000035YC, REGCN2000029YC, REVCV2000004CN, REVCV1800012CN, REVCV1800030CN, REVCV1800064CN, REVCV1800056CN, REVCV1800061CN, REVCV2000008CN, REVCV1900019CN, REGCN2000006YC, REGCN1900013YC, REGCN2000024YC, REGCN1900033YC, REGCN2000030YC, REGCN2000033YC, REVCV1700011CN, REGCN1900034YC, REGCN2000003YC, REVCV1900014CN, REVCV1800043CN, REGCN1900017YC, REVCV1800011CN, REGCN2000008YC, REGCN2000044YC, REVCV1800037CN, REVCV1800017CN, REGCN2000027YC, REGCN2000031YC, REGCN2000058YC, REGCN1900030YC, REVCV1800052CN, REVCV1900026CN, REGCN2000043YC, REGCN2000046YC, REVCV1800065CN, REVCV1900009CN, REGCN2000055YC, REGCN2000059YC, REGCN2000061YC, REGCN2000062YC, REGCN2000064YC, REGCN2000065YC, REGCN2000066YC, REGCN2000067YC, REGCN2000068YC, REGCN2000069YC, REGCN2000070YC, REGCN2000072YC, REGCN2000073YC, REGCN2000081YC, REGCN2000086YC, REGCN2000087YC, REGCN2000088YC, REGCN2000089YC, REGCN2000090YC, REVCV1800063CN, REGCN2000004YC, REVCV1800049CN, REVCV2000003CN, REVCV1700002CN, REVCV1900022CN, REGCN1900020YC, REVCV1800075CN, REVCV1900032CN, REVCV1800076CN, REGCN2000048YC, REGCN2000009YC, REGCN2000056YC, REGCN2000013YC, REGCN2000036YC, REGCN1900012YC, REVCV1800039CN, REVCV1900027CN, REGCN1900007YC, REVCV1700025CN, REVCV1800002CN, REVCV1800087CN, REGCN1900028YC, REGCN2000037YC, REGCN2000034YC, REGCN2000016YC, REVCV1900025CN, REVCV2000002CN, REGCN2000049YC, REVCV1800001CN, REVCV1900024CN, REVCV1900031CN, REVCV1900012CN, REGCN2000002YC, REVCV1800045CN, REVCV1800041CN, REGCN2000038YC, REVCV1700021CN, REVCV1800036CN, REVCV1700024CN, REVCV1800038CN, REVCV1700007CN, REVCV1800060CN, REVCV1800067CN, REGCN2000053YC, REVCV1700006CN, REGCN2000025YC, REVCV1800010CN, REVCV1900004CN, REVCV1800077CN, REVCV1700009CN, REVCV1800005CN, REGCN1900023YC, REVCV1800040CN, REVCV1900016CN, REGCN1900001YC, REVCV1700022CN, REVCV1800048CN, REVCV1800026CN, REVCV1800066CN, REVCV1700010CN, REVCV1700004CN, REVCV1800057CN, REVCV1700013CN, REGCN1900004YC, REGCN2000063YC, REGCN1900032YC, REGCN2000045YC, REVCV1800080CN, REGCN2000015YC, REGCN1900009YC, REVCV1800070CN, REGCN2000001YC, REVCV1900013CN, REGCN1900021YC, REVCV1800023CN, REVCV1700008CN, REVCV1800078CN, REGCN2000022YC, REVCV1800084CN, REVCV1800013CN, REVCV1800016CN, REVCV1900007CN, REGCN2000026YC, REGCN2000021YC, REVCV1700023CN, REGCN2000012YC, REGCN1900005YC, REGCN1900026YC, REVCV1800089CN, REVCV1700018CN, REGCN1900025YC, REGCN1900015YC, REVCV1800004CN, REGCN1900011YC, REVCV1800015CN, REVCV1800054CN, REVCV1800055CN, REVCV1900029CN, REGCN1900014YC, REVCV1900023CN, REVCV1800035CN, REGCN1900016YC, REGCN1900003YC, REGCN2000060YC, REVCV1800068CN, REVCV1800027CN, REVCV1700026CN, REGCN2000082YC, REGCN2000083YC, REGCN2000084YC, REGCN2000085YC   5590000-15: REVV81800010CN, REVV81900014CN, REVV81700003CN, REVV81700005CN, REVV81900032CN, REVV81900033CN, REVV81900011CN, REVV81800015CN, REVV81900005CN, REVV81900024CN, REVV82000022CN, REVV81700013CN, REVV81900036CN, REVV81800017CN, REVV81800021CN, REVV82000033CN, REVV81800027CN, REVV81900001CN, REVC82000019CN, REVV82000015CN, REVV81900009CN, REVV81800028CN, REVV81800029CN, REVV81700010CN, REVV81700001CN, REVV81700006CN, REVV81800024CN, REVV81800026CN, REVV82000014CN, REVV81900019CN, REVV82000012CN, REVV81900038CN, REVV81900010CN, REVV82000005CN, REVV81900018CN, REVV81800030CN, REVV81700014CN, REVV82000011CN, REVV81900034CN, REVV81900008CN, REVV81800020CN, REVV81800016CN, REVV81900030CN, REVV81900020CN, REVV82000013CN, REVV81800023CN, REVV82000028CN, REVV81800006CN, REVV82000037CN, REVV81900002CN, REVV81900029CN, REVV81900035CN, REVV81700009CN, REVV81800004CN, REVV81800001CN, REVV81700012CN, REVV81700007CN, REVV82000027CN, REVV81900023CN, REVV81900007CN, REVV81700004CN, REVV81700008CN, REVV81800009CN, REVV82000035CN, REVV81800008CN, REVV82000029CN, REVV81900006CN, REVV82000020CN, REVV81700015CN, REVV81800019CN, REVV81900015CN, REVV81800013CN, REVV81800012CN, REVV82000026CN, REVV82000032CN, REVV81800014CN, REVV81900013CN, REVV82000008CN, REVV82000024CN, REVV82000023CN, REVV81800002CN, REVV81800022CN, REVV82000030CN, REVV82000034CN, REVV82000036CN, REVV82000031CN, REVV82000001CN, REVV82000006CN, REVV81800005CN, REVV81800018CN, REVV81900022CN, REVV82000017CN, REVV81800011CN, REVV81900004CN, REVV81700002CN, REVV81900012CN, REVV81800025CN, REVV81900003CN, REVV81900026CN, REVV81800003CN, REVV82000002CN, REVV82000025CN, REVV81900028CN, REVV81900021CN, REVV82000038CN, REVV82000039CN   5590000-16: REVC82000002CN, REVC82000018CN, REVC81900005CN, REVC82000021CN, REVC82000010CN, REVC82000014CN, REVC82000011CN, REVC82000008CN, REVC82000027CN, REVC82000009CN, REVC82000006CN, REVC81900010CN, REVC81900003CN, REVC82000016CN, REVC81900004CN, REVC82000034CN, REVC82000035CN, REVC81900009CN, REVC81900011CN, REVC82000001CN, REVC82000007CN, REVC82000028CN, REVC82000024CN, REVC81900012CN, REVC81900002CN, REVC81900001CN, REVC82000017CN, REVC82000026CN, REVC82000015CN, REVC81900007CN, REVC82000020CN, REVC82000012CN, REVC82000004CN, REVC82000013CN, REVC82000025CN, REVC82000029CN, REVC82000030CN, REVC82000031CN, REVC82000033CN, REVC82000036CN   5595000-15: REVV81900016CN, REVV81900017CN  
Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information ContactGE Healthcare Service
800-437-1171
Manufacturer Reason
for Recall
GE Healthcare has become aware of a potential issue on Revolution Apex, Revolution CT with Apex Edition, Revolution CT, and Revolution CT ES systems where the table pinch protector could be damaged or missing leading to exposed table screws which could cause a laceration due to a sharp edge.
FDA Determined
Cause 2
Process change control
ActionThe manufacturer sent an "Urgent Medical Device Correction" letter (GEHC Ref# 25496) to customers with affected systems on 12/17/2020.
Quantity in Commerce1115 units
DistributionWorldwide - US Nationwide Distribution in the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NJ, NV, NY, NH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV; In the countries of Algeria, Australia, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Canada, China, Croatia, Denmark, Estonia, Finland, France, Gabon, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kenya, Korea (Republic Of), Kuwait, Lithuania, Malaysia, Malta, Mexico, Morocco, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uzbekistan, Viet Nam.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JAK
510(K)s with Product Code = JAK
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