FDA DevicesClass II
Revolution Apex Select, X-ray Computed Tomography, Model Number 5590000-27
Published: May 20, 2026Recall ID: Z-2155-2026Category: devicesCountry: US
Reason for Recall / Hazard
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 & Identification
Revolution Apex Select, X-ray Computed Tomography, Model Number 5590000-27
Additional Source Details
| Field | Value |
|---|---|
| City | Waukesha |
| State | WI |
| Event id | 98738 |
| Address 1 | 3000 N Grandview Blvd |
| Code info | UDI-DI: 00195278469700; Serial Numbers: REV242400001CN REV242400004CN REV242300006CN REV242400002CN REV242300004CN |
| Postal code | 53188-1615 |
| Report date | 20260520 |
| Product type | Devices |
| Product quantity | 5 units |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260326 |
| Initial firm notification | Letter |
| Center classification date | 20260508 |
Overview
- Recalling FirmGE Medical Systems, LLC
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - US Nationwide distribution.