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