GE Medical Systems, LLC recalls Optima XR200amx

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.

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 Service Immediately. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions. Please retain this document for your records. Please complete and return the attached acknowledgement form electronically via FMI 10967 Digital Response Form or print, fill out manually, scan, and email to Recall.10967@gehealthcare.com.

• FDA enforcement recordOfficial FDA database entry for Z-2726-2026
• FDA 510(k) clearance · K103476The device's official FDA premarket clearance record
• FDA 510(k) clearance · K142383The device's official FDA premarket clearance record
• FDA device classification · IZLOfficial FDA classification for this device type
• CFR regulation · 21 CFR 892.1720The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find GE Medical Systems, LLCSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.