🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: February 18, 2025 GE Medical Systems Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    System ID Number 907729APEX1, UDI (01)00195278460271(11)231100(21)REV2X2300082CN, Mfg. Lot/Serial Number REV2X2300082CN; System ID Number 650493REV2, UDI To be provided, Mfg. Lot/Serial Number REVVX1900036CN; System ID Number 864512APEX1, UDI (01)00195278460271(11)240500(21)REV2X2400059CN, Mfg. Lot/Serial Number REV2X2400059CN; System ID Number 832325REV, UDI (01)00195278460271(11)241000(21)REV2X2400134CN, Mfg. Lot/Serial Number REV2X2400134CN; System ID Number 281MWREVCT, UDI To be provided, Mfg. Lot/Serial Number REVVX1900008CN; System ID Number 713792ACT39, UDI To be provided, Mfg. Lot/Serial Number REVV82100006CN; System ID Number 206320REV, UDI To be provided, Mfg. Lot/Serial Number 00000441459CN5; System ID Number 206320REV2, UDI To be provided, Mfg. Lot/Serial Number REVV82200025CN; System ID Number 082421190701, UDI (01)00195278633149(11)241100(21)CBFCG2400026HM, Mfg. Lot/Serial Number CBFCG2400026HM; System ID Number DK1044CT12, UDI (01)00840682146616(11)200200(21)REV2A2000001CN, Mfg. Lot/Serial Number REV2A2000001CN; System ID Number DK1547CT02, UDI (01)00840682146616(11)210100(21)REV2A2100002CN, Mfg. Lot/Serial Number REV2A2100002CN; System ID Number 11525316, UDI To be provided, Mfg. Lot/Serial Number REV2X2400082CN; System ID Number 259056CT01, UDI (01)00195278460271(11)230800(21)REV2X2300051CN, Mfg. Lot/Serial Number REV2X2300051CN; System ID Number 11437190, UDI To be provided, Mfg. Lot/Serial Number CBGLG2400001HM; System ID Number 0850211094, UDI (01)00195278460271(11)230800(21)REV2X2300048CN, Mfg. Lot/Serial Number REV2X2300048CN; System ID Number 12622329, UDI To be provided, Mfg. Lot/Serial Number REV2X2400165CN; System ID Number M001CT06, UDI To be provided, Mfg. Lot/Serial Number Not Available; System ID Number M004CT02, UDI (01)00195278460271(11)230400(21)REV2X2300005CN, Mfg. Lot/Serial Number REV2X2300005CN; System ID Number AC002CT05, UDI (01)00840682123471(11)190100(21)REVV81900003CN, Mfg. Lot/Serial Number REVV81900003CN; System ID Number R002CT12, UDI (01)00195278460271(11)230500(21)REV2X2300012CN, Mfg. Lot/Serial Number REV2X2300012CN; System ID Number AC001CT05, UDI (01)00840682118552(11)181000(21)REVVX1800101CN, Mfg. Lot/Serial Number REVVX1800101CN
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
GE Medical Systems, LLC
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

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

Product Codes/Lot Numbers:

System ID Number 907729APEX1, UDI (01)00195278460271(11)231100(21)REV2X2300082CN, Mfg. Lot/Serial Number REV2X2300082CN; System ID Number 650493REV2, UDI To be provided, Mfg. Lot/Serial Number REVVX1900036CN; System ID Number 864512APEX1, UDI (01)00195278460271(11)240500(21)REV2X2400059CN, Mfg. Lot/Serial Number REV2X2400059CN; System ID Number 832325REV, UDI (01)00195278460271(11)241000(21)REV2X2400134CN, Mfg. Lot/Serial Number REV2X2400134CN; System ID Number 281MWREVCT, UDI To be provided, Mfg. Lot/Serial Number REVVX1900008CN; System ID Number 713792ACT39, UDI To be provided, Mfg. Lot/Serial Number REVV82100006CN; System ID Number 206320REV, UDI To be provided, Mfg. Lot/Serial Number 00000441459CN5; System ID Number 206320REV2, UDI To be provided, Mfg. Lot/Serial Number REVV82200025CN; System ID Number 082421190701, UDI (01)00195278633149(11)241100(21)CBFCG2400026HM, Mfg. Lot/Serial Number CBFCG2400026HM; System ID Number DK1044CT12, UDI (01)00840682146616(11)200200(21)REV2A2000001CN, Mfg. Lot/Serial Number REV2A2000001CN; System ID Number DK1547CT02, UDI (01)00840682146616(11)210100(21)REV2A2100002CN, Mfg. Lot/Serial Number REV2A2100002CN; System ID Number 11525316, UDI To be provided, Mfg. Lot/Serial Number REV2X2400082CN; System ID Number 259056CT01, UDI (01)00195278460271(11)230800(21)REV2X2300051CN, Mfg. Lot/Serial Number REV2X2300051CN; System ID Number 11437190, UDI To be provided, Mfg. Lot/Serial Number CBGLG2400001HM; System ID Number 0850211094, UDI (01)00195278460271(11)230800(21)REV2X2300048CN, Mfg. Lot/Serial Number REV2X2300048CN; System ID Number 12622329, UDI To be provided, Mfg. Lot/Serial Number REV2X2400165CN; System ID Number M001CT06, UDI To be provided, Mfg. Lot/Serial Number Not Available; System ID Number M004CT02, UDI (01)00195278460271(11)230400(21)REV2X2300005CN, Mfg. Lot/Serial Number REV2X2300005CN; System ID Number AC002CT05, UDI (01)00840682123471(11)190100(21)REVV81900003CN, Mfg. Lot/Serial Number REVV81900003CN; System ID Number R002CT12, UDI (01)00195278460271(11)230500(21)REV2X2300012CN, Mfg. Lot/Serial Number REV2X2300012CN; System ID Number AC001CT05, UDI (01)00840682118552(11)181000(21)REVVX1800101CN, Mfg. Lot/Serial Number REVVX1800101CN

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1303-2025

Related Recalls

Allia IGS 3 Pulse angiographic X-ray system

GE Medical Systems

Class I - Dangerous

GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.

Apr 20, 2026 Other Medical Devices Nationwide View Details →

Allia IGS Pulse angiographic X-ray system

GE Medical Systems

Class I - Dangerous

GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.

Apr 20, 2026 Other Medical Devices Nationwide View Details →

Allia Moveo angiographic X-ray system

GE Medical Systems

Class I - Dangerous

GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.

Apr 20, 2026 Other Medical Devices Nationwide View Details →