This is part of a larger recall. The most authoritative record is FDA-Device / Z-2728-2026.
GE Optima XR220amx radiographic system recalled for potential arm drop hazard
What this means
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.
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-2727-2026Want us to check the next one for you?
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