Z-2152-2026 Class II Ongoing
FDA device recall Z-2152-2026 was initiated by GE Medical Systems, LLC on March 26, 2026 and is designated Class II. 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 A… The recall status is ongoing. Affected quantity: 11 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 20, 2026
- Initiation Date
- March 26, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11 units
Product Description
Revolution Apex Plus, X-ray Computed Tomography, Model Number 5590000-25
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.
Distribution Pattern
Worldwide - US Nationwide distribution.
Code Information
UDI-DI: 00195278502179; Serial Numbers: REV282400012CN REV282400006CN REV282400038CN REV282400011CN REV282400003CN REV282400013CN REV282300006CN REV282400021CN REV282300013CN REV282400035CN REV282300022CN