AlignRT InBore Laser Documentation 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
The AlignRT InBore system, used in medical imaging, contains six lasers that help track patient position. The manufacturer failed to provide required safety information about these lasers in the instructions, which is a regulatory violation that affects user awareness and safety.
Is the Vision RT Ltd recalled? Yes. This product was recalled by FDA on August 27, 2025. Details below.
What is recalled
AlignRT InBore systems manufactured by Vision RT Ltd containing six Class 1 lasers.
Am I affected
You are affected if your medical facility uses an AlignRT InBore system manufactured by Vision RT Ltd.
What to do right now
Contact Vision RT Ltd to request updated Instructions for Use that include the required laser safety information and characteristics.
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
- Source
- FDA
- Category
- Medical Devices
- Recall ID
- fda-Z-0998-2026
- Classification
- Class II
- Recalled
- August 27, 2025
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