GE HealthCare is recalling 454 Optima XR200amx, XR220amx, and XR240amx Mobile Digital Radiographic Systems. The recall affects units that have undergone a column replacement, as some bolts in the Column Safety mechanism may be missing. If the main support cable fails while these bolts are missing, the arm holding the X-ray tube can fall suddenly. No injuries have been reported in connection with this defect.
A missing safety bolt prevents the backup mechanism from catching the X-ray arm if the primary support cable snaps. This failure causes the heavy arm and imaging equipment to drop down the column track, posing a significant risk of impact or crushing injuries to patients or medical staff beneath the device.
Quantity: 53 units
Quantity: 281 units
Quantity: 120 units
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES ยท Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.