Recall Z-2155-2026— GE Medical Systems, LLC

Name: FDA recall Z-2155-2026
Creator: U.S. Food and Drug Administration
Published: 2026-03-26

Class II · Ongoing

Class II FDA medical device recall by GE Medical Systems, LLC, initiated 2026-03-26. It names one FDA 510(k) clearance: K213715. Product: Revolution Apex Select, X-ray Computed Tomography, Model Number 5590000-27. Reason: 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..

Recalling firm: GE Medical Systems, LLC
Classification: Class II
Status: Ongoing
Initiated: 2026-03-26
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K213715 — Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex Select,Revolution CT +3 moreGe Medical Systems, LLC·cleared 2021-12-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Revolution Apex Select, X-ray Computed Tomography, Model Number 5590000-27

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.