Vision RT Ltd is recalling approximately 56 AlignRT InBore systems because the Instructions for Use (IFU) manual failed to include required safety information about the device's lasers. The system uses six Class 1 lasers to track a patient's position and movement during medical procedures, but the manual was missing specific characteristics and identifications required by federal safety standards. Vision RT is contacting affected customers to provide corrected documentation for these systems.
Without correct laser identification and safety characteristics in the user manual, medical staff may lack necessary information for the safe operation and maintenance of the device. While Class 1 lasers are considered safe under normal operation, missing regulatory safety documentation can lead to improper use or failure to follow required safety protocols.
The system contains six Class 1 lasers used for camera tracking of patient position.
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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