GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed
Summary
The FDA issued a Class II for GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed by GE Medical Systems, LLC. Reason: GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product detail.
Details
Source
Device Recall
External ID
Z-1297-2025
Action Date
2025-03-19
Status
Ongoing
Category
device
Product Description
GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed
Lot/Code Info: System ID Number: 907729APEX1, UDI (01)00195278460271(11)231100(21)REV2X2300082CN, Mfg. Lot/Serial Number REV2X2300082CN; System ID Number: 650493REV1, UDI To be provided, Mfg. Lot/Serial Number REVVX1900035CN; System ID Number: 630266CTRV, UDI (01)00195278460271(11)240800(21)REV2X2400093CN, Mfg. Lot/Serial Number REV2X2400093CN; System ID Number: 773702REVCT6ED, UDI (01)00195278460271(11)231000(21)REV2X2300071CN, Mfg. Lot/Serial Number REV2X2300071CN; System ID Number: 312996CTRV2, UDI (01)00195278460271(11)241000(21)REV2X2400126CN, Mfg. Lot/Serial Number REV2X2400126CN; System ID Number: 1000000018, UDI To be provided, Mfg. Lot/Serial Number REV2X2300074CN; System ID Number: 617726Y6REV2, UDI (01)00840682118552(11)170900(21)REVVX1700090CN, Mfg. Lot/Serial Number REVVX1700090CN; System ID Number: 617726Y6REV1, UDI (01)00840682118552(11)160700(21)REVVX1600018CN, Mfg. Lot/Serial Number REVVX1600018CN; System ID Number: 336890APEX, UDI (01)00195278460271(11)240900(21)REV2X2400116CN, Mfg. Lot/Serial Number REV2X2400116CN; System ID Number: 704801APEX, UDI (01)00195278460271(11)241000(21)REV2X2400139CN, Mfg. Lot/Serial Number REV2X2400139CN; System ID Number: 336832APEX, UDI (01)00195278460271(11)241000(21)REV2X2400129CN, Mfg. Lot/Serial Number REV2X2400129CN; System ID Number: 980993CT1, UDI (01)00840682146616(11)210700(21)REV2A2100029CN, Mfg. Lot/Serial Number REV2A2100029CN; System ID Number: 910715REV1, UDI (01)00195278460271(11)241200(21)REV2X2400155CN, Mfg. Lot/Serial Number REV2X2400155CN; System ID Number: 603650APEX1, UDI (01)00195278460271(11)240600(21)REV2X2400068CN, Mfg. Lot/Serial Number REV2X2400068CN; System ID Number: 603526APEX, UDI (01)00195278469700(11)230100(21)REV242200004CN, Mfg. Lot/Serial Number REV242200004CN; System ID Number: 973971REV161, UDI (01)00195278460271(11)241200(21)REV2X2400158CN, Mfg. Lot/Serial Number REV2X2400158CN; System ID Number: 914787APEX, UDI (01)00195278460271(11)231000(21)REV2X2300081CN, Mfg. Lot/Serial Number REV2X2300081CN; System ID Number: 718963EDCT, UDI (01)00195278460271(11)240600(21)REV2X2400070CN, Mfg. Lot/Serial Number REV2X2400070CN; System ID Number: 315473APEX1, UDI (01)00195278460271(11)241100(21)REV2X2400152CN, Mfg. Lot/Serial Number REV2X2400152CN; System ID Number: 614RMHAPEX1, UDI (01)00195278460271(11)240300(21)REV2X2400026CN, Mfg. Lot/Serial Number REV2X2400026CN; System ID Number: 724357APEX, UDI (01)00195278460271(11)230800(21)REV2X2300046CN, Mfg. Lot/Serial Number REV2X2300046CN; System ID Number: 843797REVCT2, UDI (01)00840682123471(11)211100(21)REVV82100041CN, Mfg. Lot/Serial Number REVV82100041CN; System ID Number: 806775APEX, UDI (01)00195278460271(11)231000(21)REV2X2300075CN, Mfg. Lot/Serial Number REV2X2300075CN; System ID Number: 703776APEX, UDI To be provided, Mfg. Lot/Serial Number REV2X2400167CN; System ID Number: 414805REVCT, UDI Not Applicable, Mfg. Lot/Serial Number 00000441066CN8; System ID Number: 262577REVCT, UDI (01)00195278460271(11)240500(21)REV2X2400055CN, Mfg. Lot/Serial Number REV2X2400055CN; System ID Number: 832CT000059, UDI (01)00840682146616(11)220100(21)REV2A2200006CN, Mfg. Lot/Serial Number REV2A2200006CN; System ID Number: 833CT000155, UDI (01)00195278460271(11)240500(21)REV2X2400053CN, Mfg. Lot/Serial Number REV2X2400053CN; System ID Number: AH7084CT02, UDI (01)00840682146616(11)220100(21)REV2A2200007CN, Mfg. Lot/Serial Number REV2A2200007CN; System ID Number: AH1923CT01, UDI (01)00195278460271(11)240300(21)REV2X2400024CN, Mfg. Lot/Serial Number REV2X2400024CN; System ID Number: BG4549CT04, UDI (01)00195278460271(11)230600(21)REV2X2300026CN, Mfg. Lot/Serial Number REV2X2300026CN; System ID Number: E416249APEXCTE, UDI (01)00195278460271(11)231100(21)REV2X2300087CN, Mfg. Lot/Serial Number REV2X2300087CN; System ID Number: 082421140968, UDI To be provided, Mfg. Lot/Serial Number Not Available; System ID Number: 082421140960, UDI (01)00195278633149(11)240500(21)CBFCG2400006HM, Mfg. Lot/Serial Number CBFCG2400006HM; System ID Number: 082421140959, UDI (01)00195278633149(11)240500(21)CBFCG2400004HM, Mfg. Lot/Serial Number CBFCG2400004HM; System ID Number: DK1044CT12, UDI (01)00840682146616(11)200200(21)REV2A2000001CN, Mfg. Lot/Serial Number REV2A2000001CN; System ID Number: DK1547CT01, UDI (01)00840682123471(11)210100(21)REVV82100002CN, Mfg. Lot/Serial Number REVV82100002CN; System ID Number: DK1051CT04, UDI To be provided, Mfg. Lot/Serial Number 00000442412CN3; System ID Number: CT52261701, UDI To be provided, Mfg. Lot/Serial Number REV2X2300050CN; System ID Number: M40230104, UDI (01)00840682118552(11)160600(21)REVVX1600012CN, Mfg. Lot/Serial Number REVVX1600012CN; System ID Number: REV020, UDI To be provided, Mfg. Lot/Serial Number 00000442334CN9; System ID Number: CT00486, UDI (01)00195278460271(11)231000(21)REV2X2300079CN, Mfg. Lot/Serial Number REV2X2300079CN; System ID Number: KRCT54972221, UDI To be provided, Mfg. Lot/Serial Number Not Available; System ID Number: KRCT54893311, UDI To be provided, Mfg. Lot/Serial Number Not Available; System ID Number: 0850211084, UDI To be provided, Mfg. Lot/Serial Number REV2X2300016CN; System ID Number: NO1068CT04, UDI (01)00840682118552(11)171000(21)REVVX1700106CN, Mfg. Lot/Serial Number REVVX1700106CN; System ID Number: P00652CT01, UDI (01)00195278460271(11)240200(21)REV2X2400017CN, Mfg. Lot/Serial Number REV2X2400017CN; System ID Number: PL1672CT03, UDI (01)00840682146616(11)210600(21)REV2A2100019CN, Mfg. Lot/Serial Number REV2A2100019CN; System ID Number: SA1420CT01, UDI To be provided, Mfg. Lot/Serial Number REV2X2400137CN; System ID Number: SA2973CT01, UDI To be provided, Mfg. Lot/Serial Number REV2X23000030CN; System ID Number: CT53972381, UDI To be provided, Mfg. Lot/Serial Number REV2X2400121CN; System ID Number: A201CT07, UDI (01)00195278460271(11)240200(21)REV2X2400014CN, Mfg. Lot/Serial Number REV2X2400014CN; System ID Number: AC001CT05, UDI (01)00840682118552(11)181000(21)REVVX1800101CN, Mfg. Lot/Serial Number REVVX1800101CN; System ID Number: 541010CT02, UDI (01)00840682118552(11)190900(21)REVVX1900106CN, Mfg. Lot/Serial Number REVVX1900106CN; System ID Number: THCTX24524601, UDI (01)00195278460271(11)241000(21)REV2X2400131CN, Mfg. Lot/Serial Number REV2X2400131CN; System ID Number: AE1025CT03, UDI (01)00840682118552(11)210300(21)REVVX2100010CN, Mfg. Lot/Serial Number REVVX2100010CN.
Quantity Affected: 56 units
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.
Distribution
Worldwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-02-18
Company
Waukesha, WI
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 159 device recalls issued in the same week, part of 403 device-related FDA actions this month.
GE Medical Systems, LLC has 138 FDA actions in our database, including 121 recalls and 17 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (GE Medical Systems, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does GE Medical Systems, LLC have FDA actions?
GE Medical Systems, LLC has 138 FDA actions in our database, including 121 recalls and 17 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1297-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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