| |
Class 2 Device Recall Revolution CT, Revolution CT ES |
 |
| Date Initiated by Firm |
December 17, 2020 |
| Create Date |
February 17, 2021 |
| Recall Status1 |
Terminated 3 on January 09, 2023 |
| Recall Number |
Z-1130-2021 |
| Recall Event ID |
87089 |
| 510(K)Number |
K133705 K163213 K191777
|
| Product Classification |
System, x-ray, tomography, computed - Product Code JAK
|
| Product |
System, 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, 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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 Contact |
GE 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 |
| Action |
The manufacturer sent an "Urgent Medical Device Correction" letter (GEHC Ref# 25496) to customers with affected systems on 12/17/2020. |
| Quantity in Commerce |
1115 units |
| Distribution |
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. |
| Total Product Life Cycle |
TPLC Device Report
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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.
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| 510(K) Database |
510(K)s with Product Code = JAK and Original Applicant = GE Medical Systems, L.L.C.
510(K)s with Product Code = JAK and Original Applicant = GE Medical Systems, LLC
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