FDA · Medical device recall

System… and 1 more product

Feb. 24, 2021 Class II

Date: Feb. 24, 2021
Risk class: Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
Status: Terminated
Filed by: GE Healthcare, LLC
Reason: 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.
Distribution pattern: Worldwide - 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.

2 products in this recall

System…

Product: System, X-Ray, Tomography, Computed: Revolution Apex, Revolution CT with Apex Edition
Quantity: 96 units
Codes and lots: Model Numbers: 5590000-20: REV2A1900002CN, REV2A2000013CN, REV2A2000025CN, REV2A2000006CN, REV2A2000003CN, REV2A2000015CN, REV2A1900003CN, REV2A2000007CN, REV2A2000022CN, REV2A2000010CN, REV2A2000030CN, REV2A2000029CN, REV2A2000017CN, REV2A2000001CN, REV2A2000002CN, REV2A2000031CN, REV2A2000020CN, REV2A2000024CN, REV2A2000023CN, REV2A2000012CN, REV2A2000016CN, REV2A1900001CN, REV2A2000027CN, REV2A2000028CN, REV2A2000018CN, REV2A1900005CN, REV2A2000009CN, REV2A2000026CN, REV2A2000021CN, REV2A2000011CN 5590000-21: xxx, xxx, xxx* (66 units) *serial number information current as of 01/21/2021.
Recall started: Dec. 17, 2020
Device type: System, X-Ray, Tomography, Computed
Root cause (FDA): Process change control
What the company told customers: The manufacturer sent an "Urgent Medical Device Correction" letter (GEHC Ref# 25496) to customers with affected systems on 12/17/2020.
Recall number: Z-1129-2021

System…

Product: System, X-Ray, Tomography, Computed: Revolution CT, Revolution CT ES.
Quantity: 1115 units
Codes and lots: 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…
Recall started: Dec. 17, 2020
Device type: System, X-Ray, Tomography, Computed
Root cause (FDA): Process change control
What the company told customers: The manufacturer sent an "Urgent Medical Device Correction" letter (GEHC Ref# 25496) to customers with affected systems on 12/17/2020.
Recall number: Z-1130-2021

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement reports, recall numbers Z-1129-2021, Z-1130-2021. The agency record governs; check it and the company before acting.

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