GE Healthcare, LLC Recall 87089
Description: System, X-Ray, Tomography, Computed: Revolution CT, Revolution CT ES.
GE Healthcare, LLC Recall 87089 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1130-2021 |
| Event ID | 87089 |
| Event Description | System, X-Ray, Tomography, Computed: Revolution CT, Revolution CT ES. |
| Product Type | Devices |
| 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. |
| Quantity | 1115 units |
| Recall 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. |
| Device Classification | 20210224 |
| Device Code Info | 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, 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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 |
| Center Classification Date | 20210217 |
| Recall Initiation Date | 20201217 |
| Recalling Firm | GE Healthcare, LLC |
| Initial Notification | |
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