Recall Z-2154-2026— GE Medical Systems, LLC
Class II · Ongoing
Class II FDA medical device recall by GE Medical Systems, LLC, initiated 2026-03-26. It names 3 FDA 510(k) clearances: K213715, K191777, K163213. Product: Revolution Apex, X-ray Computed Tomography, Model Number 5590000-20. 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
3 on FDA's record- K213715 — Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex Select,Revolution CT +3 more
- K191777 — Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition
- K163213 — Revolution CT
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, X-ray Computed Tomography, Model Number 5590000-20
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.