Recall Z-2728-2026 ยท IZL System, X-Ray, Mobile
GE Medical Systems, LLC
Optima XR240amx, Mobile Digital Radiographic System
| Date | Jul 13, 2026 (initiated Jun 5, 2026) |
| Status | Open, Classified |
| Reason | GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work, causing the arm with X-ray tube and collimator to drop downward on the column track. This could result in patient injury during an exam. |
| Root cause | Process control |
| Action | An URGENT MEDICAL DEVICE CORRECTION notification letter dated 6/5/26 was sent to customers. Actions to be taken by Customer/User Pending corrections from GE HealthCare, you can continue to use the system by following the instructions below: Perform a check of your device prior to each patient exam to look for the following behaviors: "Column vertical movement requires increased effort. "Column has change in resistance (i.e. movement is not smooth) during vertical movement. "Column makes abnormal noises during vertical movement. If any are observed, DO NOT use the device and call GE HealthCare |
| Quantity | 24 units |
| Distribution | Worldwide - US Nationwide and the countries of Brazil, Canada, Korea, Mexico, Saudi Arabia, Spain, UK. |
| FDA record | Open on fda.gov |