Class II

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

Vision RT Ltd · August 27, 2025

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).

Distribution

U.S. and OUS

Quantity Affected

56

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0998-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Vision RT Ltd Medical Device Recall: The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement. | SafeCheck