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 XR220amx radiographic system recalled for potential arm drop hazard

OTHERNationwide distribution

GE Optima XR220amx X-ray system recalled for arm drop risk

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

  • Contact GE HealthCare if you operate or maintain one of these systems.
  • Do not use the affected system until you confirm functional testing of the safety mechanism has been completed.
  • Check your system ID against the list provided to determine if 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
38 units
Manufactured in
3000 N Grandview Blvd, Waukesha, WI, United States
Products
Optima XR220amx, Mobile Digital-Ready Radiographic System

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2727-2026

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