Vision RT Ltd recalls The AlignRT InBore system contains six Class 1 lasers which enables the system s camera…

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).

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

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.

• FDA enforcement recordOfficial FDA database entry for Z-0998-2026
• FDA device classification · IWEOfficial FDA classification for this device type
• CFR regulation · 21 CFR 892.5780The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Vision RT LtdSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.