CLASS II Device recall · Reported 24 Feb 2021 · FDA Enforcement Report

System, X-Ray, Tomography, Computed: Revolution CT, Revolution CT ES recalled

GE Healthcare is recalling System, X-Ray, Tomography, Computed: Revolution CT, Revolution CT ES, distributed nationwide in the US. The recall was initiated on 17 Dec 2020 and the FDA has classified it as Class II.

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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

Quantity recalled1115 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1130-2021
FDA event ID: 87089
Recalling firm: GE Healthcare, Waukesha, WI
Classification: Class II
Status: Terminated
Recall initiated: 17 Dec 2020
FDA classified: 17 Feb 2021
Reported: 24 Feb 2021
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

17 Dec 2020	Recall initiated by company
17 Feb 2021	Classified by FDA	+62 days
24 Feb 2021	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

System, X-Ray, Tomography, Computed: Revolution CT, Revolution CT ES.

Where it was distributed

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.

Nationwide Alabama Arkansas Arizona California Colorado Connecticut Florida Georgia Hawaii Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine Michigan Missouri

Questions about this recall

Is System, X-Ray, Tomography, Computed: Revolution CT, Revolution CT ES recalled?

Yes. GE Healthcare recalled System, X-Ray, Tomography, Computed: Revolution CT, Revolution CT ES on 17 Dec 2020. The recall is Class II and its status is Terminated. Recall number Z-1130-2021.

Why was it recalled?

Which lots are affected?

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, 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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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from GE Healthcare

All 512

Reported	Class	Recall	Company	Reason	Where
8 Apr 2026Device	CLASS II	Signa Premier systems recalled by GE Healthcare	GE Healthcare	Other	Nationwide
11 Mar 2026Device	CLASS II	Centricity Universal Viewer Zero Footprint Client recalled	GE Healthcare	Device Malfunction	Nationwide
24 Dec 2025Device	CLASS II	GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological recalled	GE Healthcare	Device Malfunction
9 Apr 2025Device	CLASS II	Centricity Pacs-iw (Pacs-iw) recalled by GE Healthcare	GE Healthcare	Other	IL
9 Apr 2025Device	CLASS II	Centricity Centricity Pacs-iw with Universal Viewer recalled	GE Healthcare	Other	IL

Other Imaging Equipment recalls

All 2,336

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Lead & Heavy Metals	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits: Ultrasound Breast Pack recalled	Medline Industries	Sterility	Nationwide
2 Sep 2026Device	CLASS II	Alphenix Models Infx-8000C Infx-8000F Infx-8000V This device is recalled	Canon Medical System, USA	Other	Nationwide
2 Sep 2026Device	CLASS II	Merge PACS and Merge OrthoPACS recalled by Merge Healthcare	Merge Healthcare	Labeling Errors	Nationwide
19 Aug 2026Device	CLASS II	Philips Azurion recalled by Philips Medical Systems	Philips Medical Systems Nederland B.v	Lead & Heavy Metals