Reported Jan 14, 2026 · Ongoing
The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s…
Vision RT Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Vision RT Ltd · Dove House · London · N/A
Is this the product you have?
- The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement.
- Lot codes and dates
- Part Number V000629
- Amount recalled
- 56
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).
This product could cause temporary or reversible health problems — stop using it.
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