Recall Z-2153-2026 ยท JAK System, X-Ray, Tomography, Computed
GE Medical Systems, LLC
Revolution CT ES, X-ray Computed Tomography, Model Number 5590000-15
| Date | May 8, 2026 (initiated Mar 26, 2026) |
| Status | Open, Classified |
| 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. |
| Root cause | Software design |
| Action | An URGENT MEDICAL DEVICE CORRECTION notification letter dated 3/26/26 was sent to customers. Actions to be taken by Customer/User Pending corrections by GE HealthCare, you can continue to use your system by following security and cybersecurity best practices. Before the interim solution (see Product Correction section below) is applied, please follow the instructions below as identified in the respective CT system User Manuals: CAUTION: 3D or slab reconstructions provide additional supplemental information, complementing diagnosis that should be based on classical techniques. WARNING: Do not |
| Quantity | 10 units |
| Distribution | Worldwide - US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K163213 | Revolution CT Ge Medical Systems, LLC, Dec 16, 2016 |
| K191777 | Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition Ge Medical Systems, LLC, Jul 26, 2019 |
| K213715 | Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex Select,Revolution CT; Revolution CT ES; Re Ge Medical Systems, LLC, Dec 17, 2021 |