RegWardenFDA facility compliance records
Company

VISION RT LIMITED

5 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2014: 2 recalls; 2016: 1 recalls; 2018: 1 recalls; 2025: 1 recalls2’14’151’16’171’18’19’20’21’22’23’241’25’26
  • Recalls (5)

Registered facilities (3)

Recalls & enforcement

  • Class IIOngoing2025-08-27
    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 c…
  • Class IITerminated2018-08-24
    RTInterface error in the event of an I/O error between the IGC PCB and the Framegrabber PCB
  • Class IITerminated2016-06-30
    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 …
  • Class IITerminated2014-11-11
    Potential use error when the external Gate Controller is turned ON after the Vision RT software has been opened.
  • Class IITerminated2014-10-15
    Potential failure of AlignRT to assert interlock.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “VISION RT LIMITED — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9063759-vision-rt-limited/

Not open yet

Alerts for VISION RT LIMITED

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.