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RecallWatchMedical Device Safety
Class IIOngoingZ-1303-2025

GE Medical Systems, LLC recalls GE Healthcare Revolution CT ES

GE Medical Systems, LLCWaukesha, WI, United StatesReported Mar 19, 2025 · 1 year ago
Legal News Analyst ·

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

GE Healthcare Revolution CT ES, System, X-ray, Tomography, Computed

Lot / code information

UDI
(01)00195278460271(11)231100(21)REV2X2300082CN, Mfg. Lot/
Serial #
REV2X2300082CN; System ID Number 650493REV2
UDI
To be provided, Mfg. Lot/
Serial #
REVVX1900036CN; System ID Number 864512APEX1
UDI
(01)00195278460271(11)240500(21)REV2X2400059CN, Mfg. Lot/
Serial #
REV2X2400059CN; System ID Number 832325REV
UDI
(01)00195278460271(11)241000(21)REV2X2400134CN, Mfg. Lot/
Serial #
REV2X2400134CN; System ID Number 281MWREVCT
UDI
To be provided, Mfg. Lot/
Serial #
REVVX1900008CN; System ID Number 713792ACT39
Show 32 more code fields
UDI
To be provided, Mfg. Lot/
Serial #
REVV82100006CN; System ID Number 206320REV
UDI
To be provided, Mfg. Lot/
Serial #
00000441459CN5; System ID Number 206320REV2
UDI
To be provided, Mfg. Lot/
Serial #
REVV82200025CN; System ID Number 082421190701
UDI
(01)00195278633149(11)241100(21)CBFCG2400026HM, Mfg. Lot/
Serial #
CBFCG2400026HM; System ID Number DK1044CT12
UDI
(01)00840682146616(11)200200(21)REV2A2000001CN, Mfg. Lot/
Serial #
REV2A2000001CN; System ID Number DK1547CT02
UDI
(01)00840682146616(11)210100(21)REV2A2100002CN, Mfg. Lot/
Serial #
REV2A2100002CN; System ID Number 11525316
UDI
To be provided, Mfg. Lot/
Serial #
REV2X2400082CN; System ID Number 259056CT01
UDI
(01)00195278460271(11)230800(21)REV2X2300051CN, Mfg. Lot/
Serial #
REV2X2300051CN; System ID Number 11437190
UDI
To be provided, Mfg. Lot/
Serial #
CBGLG2400001HM; System ID Number 0850211094
UDI
(01)00195278460271(11)230800(21)REV2X2300048CN, Mfg. Lot/
Serial #
REV2X2300048CN; System ID Number 12622329
UDI
To be provided, Mfg. Lot/
Serial #
REV2X2400165CN; System ID Number M001CT06
UDI
To be provided, Mfg. Lot/
Serial #
t Available; System ID Number M004CT02
UDI
(01)00195278460271(11)230400(21)REV2X2300005CN, Mfg. Lot/
Serial #
REV2X2300005CN; System ID Number AC002CT05
UDI
(01)00840682123471(11)190100(21)REVV81900003CN, Mfg. Lot/
Serial #
REVV81900003CN; System ID Number R002CT12
UDI
(01)00195278460271(11)230500(21)REV2X2300012CN, Mfg. Lot/
Serial #
REV2X2300012CN; System ID Number AC001CT05
UDI
(01)00840682118552(11)181000(21)REVVX1800101CN, Mfg. Lot/
Serial #
REVVX1800101CN

What the firm is doing

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."

DistributionShow details

Worldwide distribution.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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