The AlignRT InBore system contains six Class 1 lasers recall
The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement.
Why was The AlignRT InBore system contains six Class 1 lasers 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).
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Part Number V000629
- Product
- The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement.
- Recalling firm
- Vision RT Ltd
- Quantity
- 56
- Distribution
- U.S. and OUS
- Recall date
- January 14, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)