FDA Enforcement
Class II
Ongoing
Revolution CT ES, X-ray Computed Tomography, Model Number 5590000-15
Recall: Z-2153-2026
·
Reported May 20, 2026
Enforcement
- Recall Number
- Z-2153-2026
- Event ID
- 98738
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- GE Medical Systems, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 20, 2026
- Initiation Date
- March 26, 2026
- Classification Date
- May 8, 2026
- Address
- 3000 N Grandview Blvd, Waukesha, WI, 53188-1615, United States
Description
Revolution CT ES, X-ray Computed Tomography, Model Number 5590000-15
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.
Code Info
UDI-DI: 00840682123471; Serial Numbers: REVV82200058CN REVV82200046CN REVV82100016CN REVV82200014CN REVV82100027CN REVV82200047CN REVV82100031CN REVV82400010CN REVV82200017CN REVV82400005CN
Distribution
Worldwide - US Nationwide distribution.
Quantity
10 units