Optima XR200amx, Mobile Digital-Ready Radiographic System

FDA device recall Z-2726-2026 · posted 2026-07-13 · Open, Classified

Recall details

Recalling firm

GE Medical Systems, LLC

Reason for recall

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.

Action taken

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.

Root cause

Process control

Status

Open, Classified

Product code

IZL

Quantity affected

4 units

Distribution

Worldwide - US Nationwide and the countries of Brazil, Canada, Korea, Mexico, Saudi Arabia, Spain, UK.

Date initiated

2026-06-05

Date posted

2026-07-13

Location

Waukesha, WI

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