Zap Surgical Systems has recalled 17 ZAP-X Radiosurgery Systems (Model 300150) because a software defect can cause the machine to move incorrectly. This issue happens when the system encounters multiple proximity errors during long rotations, which can cause the machine's collimator to collide with the patient or the treatment table. Facilities using these systems should stop using the devices and contact the manufacturer to arrange for a software update or correction.
The software defect could cause the heavy collimator component of the radiosurgery system to physically strike a patient's shoulders or the treatment table. This poses a significant risk of physical injury to the patient and damage to the medical equipment during use.
Recall initiated due to a software defect leading to potential collisions during gantry moves greater than 180 degrees.
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.
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Sources: FDA iRES · Raw API Response
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