Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The AlignRT InBore system contains six Class 1 lasers which Recalled by Vision RT Ltd Due to Vision RT is informing customers of an omission...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Vision RT Ltd directly.
Affected Products
The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement.
Quantity: 56
Why Was This 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).
Where Was This Sold?
U.S. and OUS
About Vision RT Ltd
Vision RT Ltd has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report