FDA-Device2026-07-22Class IIPROCESSING DEFECT

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

OTHERNationwide distribution

GE Optima XR radiography systems recalled for arm drop risk

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
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
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

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