FDA DevicesClass II
Revolution Apex Plus, X-ray Computed Tomography, Model Number 5590000-25
Published: May 20, 2026Recall ID: Z-2152-2026Category: 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 Plus, X-ray Computed Tomography, Model Number 5590000-25
Additional Source Details
| Field | Value |
|---|---|
| City | Waukesha |
| State | WI |
| Event id | 98738 |
| Address 1 | 3000 N Grandview Blvd |
| Code info | UDI-DI: 00195278502179; Serial Numbers: REV282400012CN REV282400006CN REV282400038CN REV282400011CN REV282400003CN REV282400013CN REV282300006CN REV282400021CN REV282300013CN REV282400035CN REV282300022CN |
| Postal code | 53188-1615 |
| Report date | 20260520 |
| Product type | Devices |
| Product quantity | 11 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.