System, X-Ray, Tomography, Computed: Revolution CT, Revolution CT ES.
FDA Device Recall #Z-1130-2021 — Class II — December 17, 2020
Recall Summary
| Recall Number | Z-1130-2021 |
| Classification | Class II — Moderate risk |
| Date Initiated | December 17, 2020 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | GE Healthcare, LLC |
| Location | Waukesha, WI |
| Product Type | Devices |
| Quantity | 1115 units |
Product Description
System, X-Ray, Tomography, Computed: Revolution CT, Revolution CT ES.
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.
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.
Lot / Code Information
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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
Other Recalls from GE Healthcare, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1566-2022 | Class II | (1) GE Centricity Universal Viewer 6.0, Model 2... | Jul 15, 2022 |
| Z-1430-2022 | Class II | SIGNA Premier magnetic resonance scanner, model... | Jun 24, 2022 |
| Z-1466-2022 | Class II | Centricity PACS Software Version 7.0 SP0.0.4.7 | Jun 14, 2022 |
| Z-1333-2022 | Class II | GE Centricity Universal Viewer Zero Footprint. ... | Jun 8, 2022 |
| Z-1511-2022 | Class II | Service manuals for the CT, PET, or NM table as... | Jun 2, 2022 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.