Recall Z-0998-2026
Vision RT Ltd · initiated August 27, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement.
Codes / lots: Part Number V000629
Reason for recall
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).
FDA-determined cause: Radiation Control for Health and Safety Act
Action taken
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.
Details
- Recall number
- Z-0998-2026
- Initiated
- August 27, 2025
- Posted by FDA
- January 7, 2026
- Product code
- IWE – Monitor, Patient Position, Light-Beam
- Quantity
- 56
- Distribution
- U.S. and OUS
- Recalling firm
- Vision RT Ltd, London