Vision RT Recalls
6 recalls on record · December 3, 2014 to January 14, 2026 · Medical Devices
Recalls by year
14
15
16
18
26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
January 14, 2026Medical DevicesFDA
Vision RT Ltd recalls The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position
Hazard: 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).
October 10, 2018Medical DevicesFDA
Vision RT Ltd recalls Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant only. The AlignRT is a video-based three-d
Hazard: RTInterface error in the event of an I/O error between the IGC PCB and the Framegrabber PCB
August 31, 2016Medical DevicesFDA
Vision RT Ltd recalls TrueBeam¿ Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System, K140528. The TrueBeam and Edge Systems a
Hazard: Vision RT Ltd received three (3) reports from different sites that discovered the following issue, unintended changes were made to planned couch parameters, specifically the couch rotation parameter, during patient set-up for the Optical Surface Monitoring System [OSMS]. 1. CRM 3194, No Serious Injury, No MDR, Aware date: Dec 11, 2015 2. CRM 3321, No Patient Involved, No MDR, Aware date: Jan 19, 2016 3. CRM 4570, No Serious Injury, No MDR, Aware date: March 15, 2016 No patient harm was reported in any of these cases.
August 31, 2016Medical DevicesFDA
Vision RT Ltd recalls AlignRT¿ Plus [private label-OSMS] K123371: The AlignRT Plus system is indicated for use to position and monitor patien
Hazard: Vision RT Ltd received three (3) reports from different sites that discovered the following issue, unintended changes were made to planned couch parameters, specifically the couch rotation parameter, during patient set-up for the Optical Surface Monitoring System [OSMS]. 1. CRM 3194, No Serious Injury, No MDR, Aware date: Dec 11, 2015 2. CRM 3321, No Patient Involved, No MDR, Aware date: Jan 19, 2016 3. CRM 4570, No Serious Injury, No MDR, Aware date: March 15, 2016 No patient harm was reported in any of these cases.
January 14, 2015Medical DevicesFDA
Vision Rt Inc recalls AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a pati
Hazard: Potential use error when the external Gate Controller is turned ON after the Vision RT software has been opened.
December 3, 2014Medical DevicesFDA
Vision Rt Inc recalls AlignRT- Intended for prescription use. The system is indicated for use during simulation, setup and stereotactic radio
Hazard: Potential failure of AlignRT to assert interlock.