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RecallWatchMedical Device Safety
Class IIOngoingZ-1299-2025

GE Medical Systems, LLC recalls GE Healthcare Revolution Apex Expert

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 Apex Expert, System, X-ray, Tomography, Computed

Lot / code information

UDI
(01)00195278460271(11)231100(21)REV2X2300082CN, Mfg. Lot/
Serial #
REV2X2300082CN; System ID Number 205608CT
UDI
(01)00840682123471(11)180800(21)REVV81800010CN, Mfg. Lot/
Serial #
REVV81800010CN; System ID Number 256265STCT
UDI
(01)00195278460271(11)230600(21)REV2X2300021CN, Mfg. Lot/
Serial #
REV2X2300021CN; System ID Number 205699CTREV
UDI
t Applicable, Mfg. Lot/
Serial #
00000442592CN2; System ID Number 480342APEX
UDI
(01)00840682146616(11)220900(21)REV2A2200072CN, Mfg. Lot/
Serial #
REV2A2200072CN; System ID Number 480342APEX1
Show 74 more code fields
UDI
(01)00195278460271(11)240600(21)REV2X2400065CN, Mfg. Lot/
Serial #
REV2X2400065CN; System ID Number 480342APEX3
UDI
(01)00195278460271(11)240600(21)REV2X2400067CN, Mfg. Lot/
Serial #
REV2X2400067CN; System ID Number 11320
UDI
To be provided, Mfg. Lot/
Serial #
REVVX2000033CN; System ID Number 949250APEX
UDI
(01)00195278460271(11)230500(21)REV2X2300008CN, Mfg. Lot/
Serial #
REV2X2300008CN; System ID Number 858657APEX
UDI
(01)00840682118552(11)160900(21)REVVX1600034CN, Mfg. Lot/
Serial #
REVVX1600034CN; System ID Number 858824REV
UDI
(01)00195278460271(11)241100(21)REV2X2400147CN, Mfg. Lot/
Serial #
REV2X2400147CN; System ID Number 858824APEX
UDI
t Applicable, Mfg. Lot/
Serial #
00000443327CN2; System ID Number 310423CT
UDI
(01)00840682118552(11)211200(21)REVVX2100047CN, Mfg. Lot/
Serial #
REVVX2100047CN; System ID Number 707257APEX1
UDI
(01)00195278460271(11)231000(21)REV2X2300077CN, Mfg. Lot/
Serial #
REV2X2300077CN; System ID Number 714456APEX
UDI
(01)00195278460271(11)231200(21)REV2X2300094CN, Mfg. Lot/
Serial #
REV2X2300094CN; System ID Number 650493REV1
UDI
To be provided, Mfg. Lot/
Serial #
REVVX1900035CN; System ID Number 650493REV2
UDI
To be provided, Mfg. Lot/
Serial #
REVVX1900036CN; System ID Number 818708CTWSO
UDI
(01)00840682146616(11)220900(21)REV2A2200065CN, Mfg. Lot/
Serial #
REV2A2200065CN; System ID Number 310222REVO
UDI
t Applicable, Mfg. Lot/
Serial #
00000445059CN9; System ID Number 719227APEX1
UDI
(01)00195278460271(11)240200(21)REV2X2400019CN, Mfg. Lot/
Serial #
REV2X2400019CN; System ID Number 970945CT
UDI
(01)00195278460271(11)240400(21)REV2X2400046CN, Mfg. Lot/
Serial #
REV2X2400046CN; System ID Number 203576EDAPEX
UDI
(01)00195278460271(11)240300(21)REV2X2400021CN, Mfg. Lot/
Serial #
REV2X2400021CN; System ID Number 860224EDAPEX
UDI
(01)00195278460271(11)240500(21)REV2X2400050CN, Mfg. Lot/
Serial #
REV2X2400050CN; System ID Number 203276APEX1
UDI
(01)00195278460271(11)240800(21)REV2X2400095CN, Mfg. Lot/
Serial #
REV2X2400095CN; System ID Number 302744APEX
UDI
(01)00195278460271(11)240600(21)REV2X2400078CN, Mfg. Lot/
Serial #
REV2X2400078CN; System ID Number 561737APEX1
UDI
(01)00195278460271(11)240900(21)REV2X2400114CN, Mfg. Lot/
Serial #
REV2X2400114CN; System ID Number 561737APEX2
UDI
(01)00195278460271(11)240900(21)REV2X2400112CN, Mfg. Lot/
Serial #
REV2X2400112CN; System ID Number 786243APEX1
UDI
(01)00195278460271(11)230900(21)REV2X2300059CN, Mfg. Lot/
Serial #
REV2X2300059CN; System ID Number 305323APEX
UDI
(01)00195278460271(11)240900(21)REV2X2400123CN, Mfg. Lot/
Serial #
REV2X2400123CN; System ID Number 904UFNAPEX
UDI
(01)00195278460271(11)230300(21)REV2X2300001CN, Mfg. Lot/
Serial #
REV2X2300001CN; System ID Number 863680APEX
UDI
(01)00195278460271(11)230900(21)REV2X2300057CN, Mfg. Lot/
Serial #
REV2X2300057CN; System ID Number 786596APEX
UDI
(01)00195278460271(11)230900(21)REV2X2300068CN, Mfg. Lot/
Serial #
REV2X2300068CN; System ID Number 786596REV
UDI
(01)00840682118552(11)180900(21)REVVX1800093CN, Mfg. Lot/
Serial #
REVVX1800093CN; System ID Number 813972APEX
UDI
(01)00195278460271(11)230800(21)REV2X2300041CN, Mfg. Lot/
Serial #
REV2X2300041CN; System ID Number 813972APEX2
UDI
(01)00195278460271(11)240700(21)REV2X2400088CN, Mfg. Lot/
Serial #
REV2X2400088CN; System ID Number 813972APEX3
UDI
(01)00195278460271(11)241000(21)REV2X2400135CN, Mfg. Lot/
Serial #
REV2X2400135CN; System ID Number 770219APEX1
UDI
(01)00195278460271(11)240800(21)REV2X2400100CN, Mfg. Lot/
Serial #
REV2X2400100CN; System ID Number 478633REVO
UDI
(01)00840682118552(11)190200(21)REVVX1900027CN, Mfg. Lot/
Serial #
REVVX1900027CN; System ID Number 808522RCT
UDI
t Applicable, Mfg. Lot/
Serial #
00000441716CN8; System ID Number 630266CTRV
UDI
(01)00195278460271(11)240800(21)REV2X2400093CN, Mfg. Lot/
Serial #
REV2X2400093CN; System ID Number 773702REVCT6ED
UDI
(01)00195278460271(11)231000(21)REV2X2300071CN, Mfg. Lot/
Serial #
REV2X2300071CN; System ID Number 336884APEX
UDI
(01)00195278460271(11)240500(21)REV2X2400064CN, Mfg. Lot/
Serial #
REV2X2400064CN

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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