Orthoscan, Inc. is recalling approximately 163 Ziehm Mobile C-arm X-ray systems because a mechanical defect in the wired hand switch may cause the unit to release radiation unexpectedly. If the hand switch is dropped or hit, internal parts can break and trigger X-ray emission without the operator intending to start it. No incidents or injuries have been reported to date, but the manufacturer is taking corrective action to address this safety risk.
A damaged switching element in the hand switch can cause the X-ray unit to initiate radiation unintentionally. This poses a risk of unplanned radiation exposure to both patients and medical staff during clinical procedures.
Digital Mobile C-arm
Interventional fluoroscopic x-ray system
X-ray, tomography, computed system
Interventional fluoroscopic x-ray system
Iterventional fluoroscopic x-ray system
Interventional fluoroscopic x-ray system
Interventional fluoroscopic x-ray system
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 · Raw API Response
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