LEONI CIA CABLE SYSTEMS is recalling 4 units of the ORION System, an electro-mechanical robotic arm used for patient positioning during radiation therapy and radiology treatments. The systems, specifically those using software versions OSS v6.0 and OSS v7.0, can experience sudden acceleration or unintended short movements after a motion interruption. This defect could cause the robotic arm to move unexpectedly, potentially resulting in a collision between the patient and stationary objects in the treatment room. These units were distributed in Massachusetts and Tennessee.
The robotic arm may suddenly accelerate or move a short distance without warning once movement is resumed after an unforeseen interruption, which can lead to a patient colliding with stationary components of the treatment room, potentially causing physical injury.
Manufacturer Correction
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.
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Sources: FDA iRES · Raw API Response
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