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

Medical DevicesSource: FDA (device) · Date: 2026-01-14

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Vision RT Ltd
Product
The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement.
Reason / hazard
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).
Classification
Class II
Status
Ongoing
Distribution / sold at
U.S. and OUS
Recall initiated
2025-08-27
Code info
Part Number V000629
Product quantity
56
Voluntary mandated
FDA Mandated
City
London
Country
United Kingdom
Event id
98236
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