FDA recall, , Moderate risk
Vision RT AlignRT InBore System
The AlignRT InBore system has an omission in its Instructions for Use regarding laser information.
Summary by Recall Canary from the FDA notice
What happened
Vision RT Ltd, located in London, United Kingdom, is informing customers of an omission identified in the Instructions for Use for the AlignRT InBore system. The system contains six Class 1 lasers which enables the system's cameras to track the patient's position and movement.
Information identifying the lasers and their characteristics was omitted as required by 21 CFR 1040,10(h), via conformance with recognized consensus standard IEC 60825-1 Ed. The company began the recall on August 27, 2025, and the FDA classified it on January 6, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Compare these details with yours, then check the recall notice to see which units are recalled.
The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement.
Recall details
- Company began the recall
- Sold in
U.S. and OUS
- Company
- Vision RT LtdLondon, United Kingdom
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98236
- Recall number
- Z-0998-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Classified by FDA
Added to FDA's Enforcement Report
In FDA's weekly enforcement report
Listed on Recall Canary
