Vision RT Ltd Dove House Arcadia Avenue London United Kingdom Recalls

AlignRT InBore System (Vision RT) – Laser Information Omission (2025)

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).