GE Optima XR200/220/240amx radiography systems recalled for potential arm drop hazard
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
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2728-2026Also reported as
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