This is part of a larger recall. The most authoritative record is FDA-Device / Z-2728-2026.

FDA-Device2026-07-22Class IIPROCESSING DEFECT

GE Optima XR200/220/240amx X-ray system recalled for arm drop hazard after column replacement

OTHERNationwide distribution

GE Optima X-ray systems recalled for potential arm drop hazard

GE HealthCare identified that certain Optima XR200, XR220, and XR240amx X-ray systems may not have undergone proper safety testing after column replacement. If an internal cable fails, the safety mechanism could malfunction, causing the X-ray arm to drop unexpectedly during use, potentially injuring patients.

  • If you operate one of these systems, contact GE HealthCare immediately to verify whether your unit underwent column replacement and requires inspection.
  • Do not use the system for patient exams until safety testing and any necessary repairs are completed.
  • Request confirmation that the safety pawl has been functionally tested to ensure proper assembly.
Hazard

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.

Sold states
Worldwide - US Nationwide and the countries of Brazil, Canada, Korea, Mexico, Saudi Arabia, Spain, UK.
Affected count
4 units
Manufactured in
3000 N Grandview Blvd, Waukesha, WI, United States
Products
Optima XR200amx, Mobile Digital-Ready Radiographic System

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2726-2026

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