Vision RT Ltd recalls The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s positio…

Recall date

August 27, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0998-2026

FDA classification

Class II

Brand / firm

Vision RT Ltd

Sold / distributed

U.S. and OUS

Why it was recalled

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).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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