GE Healthcare Revolution CT ES, System, X-ray, Tomography, Computed
GE Medical Systems, LLC · GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the…
Open FDA's page for this record- Cfres ID
- 212667
- Product res number
- Z-1303-2025
- Event date initiated
- 2025-02-18
- Event date posted
- 2025-03-07
- Recall status
- Open, Classified
- Res event number
- 96370
- Product code
- JAK
- Product description
- GE Healthcare Revolution CT ES, System, X-ray, Tomography, Computed
- Firm FEI number
- 2126677
- Recalling firm
- GE Medical Systems, LLC
- Address 1
- 3000 N Grandview Blvd
- City
- Waukesha
- State
- WI
- Postal code
- 53188-1615
- Additional info contact
- GE HealthCare Service 800-437-1171
- Root cause description
- Process change control
- Product quantity
- 21 units
- Distribution pattern
- Worldwide distribution.
- Code info
System ID Number 907729APEX1, UDI (01)00195278460271(11)231100(21)REV2X2300082CN, Mfg. Lot/Serial Number REV2X2300082CN; System ID Number 650493REV2, UDI To be provided, Mfg. Lot/Serial Number REVVX1900036CN; System ID Number 864512APEX1, UDI (01)00195278460271(11)240500(21)REV2X2400059CN, Mfg. Lot/Serial Number REV2X2400059CN; System ID Number 832325REV, UDI (01)00195278460271(11)241000(21)REV2X2400134CN, Mfg. Lot/Serial Number REV2X2400134CN; System ID Number 281MWREVCT, UDI To be provided, Mfg. Lot/Serial Number REVVX1900008CN; System ID Number 713792ACT39, UDI To be provided, Mfg. Lot/Serial Number REVV82100006CN; System ID Number 206320REV, UDI To be provided, Mfg. Lot/Serial Number 00000441459CN5; System ID Number 206320REV2, UDI To be provided, Mfg. Lot/Serial Number REVV82200025CN; System ID Number 082421190701, UDI (01)00195278633149(11)241100(21)CBFCG2400026HM, Mfg. Lot/Serial Number CBFCG2400026HM; System ID Number DK1044CT12, UDI (01)00840682146616(11)200200(21)REV2A2000001CN, Mfg. Lot/Serial Number REV2A2000001CN; System ID Number DK1547CT02, UDI (01)00840682146616(11)210100(21)REV2A2100002CN, Mfg. Lot/Serial Number REV2A2100002CN; System ID Number 11525316, UDI To be provided, Mfg. Lot/Serial Number REV2X2400082CN; System ID Number 259056CT01, UDI (01)00195278460271(11)230800(21)REV2X2300051CN, Mfg. Lot/Serial Number REV2X2300051CN; System ID Number 11437190, UDI To be provided, Mfg. Lot/Serial Number CBGLG2400001HM; System ID Number 0850211094, UDI (01)00195278460271(11)230800(21)REV2X2300048CN, Mfg. Lot/Serial Number REV2X2300048CN; System ID Number 12622329, UDI To be provided, Mfg. Lot/Serial Number REV2X2400165CN; System ID Number M001CT06, UDI To be provided, Mfg. Lot/Serial Number Not Available; System ID Number M004CT02, UDI (01)00195278460271(11)230400(21)REV2X2300005CN, Mfg. Lot/Serial Number REV2X2300005CN; System ID Number AC002CT05, UDI (01)00840682123471(11)190100(21)REVV81900003CN, Mfg. Lot/Serial Number REVV81900003CN; System ID Number R002CT12, UDI (01)00195278460271(11)230500(21)REV2X2300012CN, Mfg. Lot/Serial Number REV2X2300012CN; System ID Number AC001CT05, UDI (01)00840682118552(11)181000(21)REVVX1800101CN, Mfg. Lot/Serial Number REVVX1800101CN
- Reason for recall
GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol) leaking onto the floor near the base of the gantry. The fluid is visible as it has a blue color. It is not corrosive and is not at a harmful temperature. However, there is a potential for injury if the fluid is not noticed and a person slips and/or falls.
- Action
GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 02/18/2025 via letter delivered using a traceable means. The notice explained the issue, safety issue, and requested the following actions be taken: "You can continue to use your system. Please monitor the floor near the base of the gantry for any accumulation of blue fluid. If blue fluid is observed, wear nitrile or rubber gloves, clean up the fluid by absorbing it with a noncombustible absorbent material, and dispose of the absorbent material in a suitable container for disposal. Please contact your local GE HealthCare service representative if any blue fluid is observed. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions. Please complete and return the attached acknowledgement form to recall.25504@gehealthcare.com."
- K numbers
- K163213, K191777, K213715
- Harmonized identifiers (openFDA)
- Device name
- System, X-Ray, Tomography, Computed
- Medical specialty description
- Radiology
- Regulation number
- 892.1750
- Device class
- 2
- K number
- K151376, K183204, K896456, K252217, K974344, K840860, K113287, K913485, K003736, K961464, K894542, K032243, K041521, K820688, K192763, K250970, K023687, K213096, K003639, K023332, K991553, K803181, K012238, K243523, K772291, K173244, K171013, K211180, K173821, K192188, K974455, K223424, K910375, K022239, K241200, K241440, K091103, K203699, K260391, K201586 +787 more
- Registration number
- 3007225492, 3027338963, 3018094310, 9617978, 3015223550, 3018423337, 3002807636, 3015169361, 3010703925, 3003768277, 3029521953, 1066019, 3017375271, 3009154005, 3004962788, 9616567, 3004091527, 3012957335, 3010398867, 3016965352, 2247992, 3003575350, 3002808157, 1054713, 3006209933, 3004857110, 3008114965, 3026047529, 3043512431, 3003477135, 3008284470, 3009196578, 3031503890, 1000246715, 3019216, 3001722928, 3013679558, 3004753774, 3005156333, 3011015597 +125 more
- FEI number
- 3007225492, 3027338963, 3018094310, 3015223550, 3018423337, 3002807636, 3015169361, 3010703925, 3002807903, 3008581796, 3029521953, 3003079232, 1000139922, 3017375271, 3009154005, 3004962788, 3004091527, 3012957335, 3010398867, 3016965352, 3003575350, 3002808157, 3002808529, 3002808382, 1000123143, 3006209933, 3004857110, 3008114965, 3026047529, 3043512431, 3003477135, 3008284470, 3009196578, 3000206435, 3031503890, 1000246715, 3019216, 3001722928, 3013679558, 3004753774 +125 more