GE Medical Systems, LLC: Medical Device Recall in 2025 - (Recall #: Z-1300-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

GE Healthcare Revolution Apex Plus, System, X-ray, Tomography, Computed

Product Classification:

Class II

Date Initiated: February 18, 2025

Date Posted: March 19, 2025

Recall Number: Z-1300-2025

Event ID: 96370

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.

Status: Ongoing

Product Quantity: 4 units

Code Information:

System ID Number 907729APEX1, UDI (01)00195278460271(11)231100(21)REV2X2300082CN, Mfg. Lot/Serial Number REV2X2300082CN; System ID Number 336832APEX, UDI (01)00195278460271(11)241000(21)REV2X2400129CN, Mfg. Lot/Serial Number REV2X2400129CN; System ID Number 973971CTREV, UDI (01)00840682118552(11)160600(21)REVVX1600010CN, Mfg. Lot/Serial Number REVVX1600010CN; System ID Number 513584APEX1, UDI (01)00840682146616(11)230300(21)REV2A2300023CN, Mfg. Lot/Serial Number REV2A2300023CN

Distribution Pattern:

Worldwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated