| | Class 2 Device Recall Revolution CT and Revolution Apex systems |  |
| Date Initiated by Firm | February 18, 2025 |
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| Date Posted | March 07, 2025 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1297-2025 |
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| Recall Event ID |
96370 |
| 510(K)Number | K163213 K191777 K213715 |
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| Product Classification |
System, x-ray, tomography, computed - Product Code JAK
|
| Product | GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed |
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| Code Information |
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. |
Recalling Firm/
Manufacturer |
GE Medical Systems, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
|
| For Additional Information Contact | GE HealthCare Service
800-437-1171 |
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Manufacturer 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. |
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FDA Determined
Cause 2 | Process change control |
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| 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." |
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| Quantity in Commerce | 56 units |
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| Distribution | Worldwide distribution. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = JAK
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