London, United Kingdom
Vision RT Ltd recalls
2 recalls recorded since 2018, most recently on 27 August 2025. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)1
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 27 August 2025
- 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).
- Distribution
- U.S. and OUS
- Initiated
- FDA Mandated
- Recall number
- Z-0998-2026
- The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement.
Terminated Class II Medical devices
- Recall started
- 24 August 2018
- Terminated
- 8 July 2022
- Reason
- RTInterface error in the event of an I/O error between the IGC PCB and the Framegrabber PCB
- Distribution
- Nationwide Foreign: Australia, Austria, Azerbaijan, Belgium, Brunei, Bulgaria, Canada, China, Croatia, Denmark, Finland, Georgia, Germany, India, Israel, Italy, Japan, Korea, Lithuania, Malaysia, Morocco, Norway, Poland, Portugal, Puerto Rico, Singapore, Spain, Sweden, Switzerland, Taiwan, Thaila
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0065-2019
- Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant only. The AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D be
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.