GE Medical Systems, LLC recalled Optima XR200amx Mobile Digital-Ready Radiographic Systems on June 5, 2026, according to the FDA. The recall addresses a potential patient injury hazard if the Column Safety mechanism fails due to unconfirmed safety pawl assembly.
How to tell if you have it
- Brand: GE Medical Systems
- Product: Optima XR200amx, Mobile Digital-Ready Radiographic System
- UDI-DI: 00840682115278
- System IDs: 419383DP3, 773792XR200, 856355OPT, FEB520100
The hazard
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.
Context
GovInfoNow's records show GE Medical Systems, LLC has 27 other recalls on record since March 30, 2018. Other recent recalls include a May 1, 2026 issue involving the canopy soffit beneath the control panel end of the device and an April 20, 2026 recall for Allia IGS Pulse X-ray Systems regarding electrical shock risks. Similar product recalls include a January 26, 2026 Philips Azurion 5 M12 System Software Recall for unexpected table movement risk and a December 10, 2025 GE Maxxus Nuclear Medicine Systems Recall for detector fall injury risk.