The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement.

Reason for Recall

Vision RT is informing customers of an omission identified in the Instructions for Use for AlignRT InBore systems

Information identifying the lasers and their characteristics was omitted from the Instructions for Use for the subject system as required by 21 CFR 1040,10(h), via conformance with recognized consensus standard IEC 60825-1 Ed. 3 (FDA Laser Notice 56).