BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-0998-2026 · Reported January 14, 2026

    Enforcement

    Recall Number
    Z-0998-2026
    Event ID
    98236
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Vision RT Ltd
    Voluntary / Mandated
    FDA Mandated
    Report Date
    January 14, 2026
    Initiation Date
    August 27, 2025
    Classification Date
    January 6, 2026
    Address
    Dove House, Arcadia Avenue, London, N/A, United Kingdom

    Description

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

    Reason

    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).

    Code Info

    Part Number V000629

    Distribution

    U.S. and OUS

    Quantity

    56