Recall Z-0998-2026 ยท IWE Monitor, Patient Position, Light-Beam
Vision RT Ltd
The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement.
| Date | Jan 7, 2026 (initiated Aug 27, 2025) |
| Status | Open, Classified |
| Reason | 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). |
| Root cause | Radiation Control for Health and Safety Act |
| Action | 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. |
| Quantity | 56 |
| Distribution | U.S. and OUS |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.