Vision RT Ltd
5 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (5)
Devices registered here (1)
- Accelerator, Linear, MedicalProduct code IYE (opens in a new tab) · Class II · Radiology · 21 CFR 892.5050
Recalls & enforcement
- Class IIOngoing2025-08-27Vision 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 c…
- Class IITerminated2018-08-24RTInterface error in the event of an I/O error between the IGC PCB and the Framegrabber PCB
- Class IITerminated2016-06-30Vision 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 …
- Class IITerminated2014-11-11Potential use error when the external Gate Controller is turned ON after the Vision RT software has been opened.
- Class IITerminated2014-10-15Potential failure of AlignRT to assert interlock.
Related
- All facilities operated by VISION RT LIMITED
- VISION RT LIMITED (GB)
- Demant Technology Centre Sp. z o.o. (PL)
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Vision RT Ltd (FEI 3014428919) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3014428919-vision-rt-ltd/
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