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Medium risk Electronics & LightingClass II

Vision RT Ltd Recall

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

Updated August 27, 2025

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

Is the Vision RT Ltd recalled? Yes. This product was recalled by FDA on August 27, 2025. Details below.

What is recalled

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

Am I affected

You may be affected if you own this product. Check the brand, model, and lot/date codes listed in the recall against your item.

What to do right now

FDA Mandated

The 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).

Brands affected

Vision RT Ltd
Source
FDA
Category
Electronics & Lighting
Recall ID
fda-Z-0998-2026
Classification
Class II
Recalled
August 27, 2025
Read the official notice

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