FDA-Device2026-07-22Class IIPROCESSING DEFECT

GE Optima XR200/220/240amx radiography systems recalled for potential arm drop hazard

OTHERNationwide distributionMedical devices

What this means

GE HealthCare identified that some Optima XR200/220/240amx systems that underwent column replacement may not have had proper safety testing completed. If an internal cable fails, the safety mechanism could malfunction, allowing the X-ray arm to drop unexpectedly during patient exams.

If your facility operates an affected Optima XR200/220/240amx system, contact GE HealthCare immediately for guidance
Do not use the system until you receive instructions from GE HealthCare
Check your system ID against the list provided by GE HealthCare to confirm whether your unit is affected

The agency's original wording

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.

Intended for

Adults

Illnesses reported

None reported

Sold states

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

Affected count

24 units

Manufactured in

3000 N Grandview Blvd, Waukesha, WI, United States

Products

Optima XR240amx, Mobile Digital Radiographic System

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2728-2026

Also reported as

FDA-Device2026-07-22
GE Optima XR200/220/240amx X-ray system recalled for arm drop hazard after column replacement
FDA-Device2026-07-22
GE Optima XR220amx radiographic system recalled for potential arm drop hazard

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