FDA Medical devices recall ·
Revolution Apex Select, X-ray Computed Tomography, Model Number 5590000-27 recall
- Recall number
- Z-2155-2026
- Date
- (initiated March 26, 2026)
- Company / brand
- GE Medical Systems, LLC
3000 N Grandview Blvd, Waukesha, WI, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 5 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Revolution Apex Select, X-ray Computed Tomography, Model Number 5590000-27
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 00195278469700; Serial Numbers: REV242400001CN REV242400004CN REV242300006CN REV242400002CN REV242300004CN
Distribution
Worldwide - US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2155-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.