Z-2152-2026Class II

GE Medical Systems, LLC

Recalling firm

Product type

Device

Status

Ongoing

Report date

2026-05-20

Distribution

Worldwide - US Nationwide distribution.

Firm state

Product quantity

11 units

Initiated by

Voluntary: Firm initiated

SPEQ quality domain

Data Integrity

Reason for recall

GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.

Product description

Revolution Apex Plus, X-ray Computed Tomography, Model Number 5590000-25

Code / lot info

UDI-DI: 00195278502179; Serial Numbers: REV282400012CN REV282400006CN REV282400038CN REV282400011CN REV282400003CN REV282400013CN REV282300006CN REV282400021CN REV282300013CN REV282400035CN REV282300022CN

Other recalls SPEQ maps to Data Integrity

2026-07-15Class IICMR SURGICAL LIMITED 2026-07-15Class IIMedtronic MiniMed, Inc.2026-07-01Class IIIPG Medical Corporation 2026-06-24Class IIMedtronic Navigation, Inc.-Boxborough

See all Data Integrity recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.