GE Healthcare Revolution Apex Select, 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
- 212665
- Product res number
- Z-1301-2025
- 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 Apex Select, System, X-ray, Tomography, Computed
- Code info
- System ID Number 907729APEX1, UDI (01)00195278460271(11)231100(21)REV2X2300082CN, Mfg. Lot/Serial Number REV2X2300082CN
- 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
- 1 unit
- Distribution pattern
- Worldwide distribution.
- 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
- 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