AlignRT InBore System (Vision RT) – Laser Information Omission (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement.
Brand
Vision RT Ltd Dove House Arcadia Avenue London United Kingdom
Lot Codes / Batch Numbers
Part Number V000629
Products Sold
Part Number V000629
Vision RT Ltd Dove House Arcadia Avenue London United Kingdom is recalling The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track th due to Vision RT is informing customers of an omission identified in the Instructions for Use for AlignRT InBore systems. Information identifying the lasers . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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).
Recommended Action
Per FDA guidance
Vision RT wrote to inform customers of an omission that they have identified in the Instructions for Use for AlignRT InBore systems. This notification contained information for users of AlignRT InBore systems on the content omitted and how to access the corrected Instructions for Use.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026