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AlignRT Plus Workstation Z2

by Vision RT Limited

AlignRT Plus Workstation Z2 is a Class II device made by Vision RT Limited, cleared under FDA 510(k) K123371 on 8 Jan 2013 and listed in FDA GUDID since 23 Sep 2021 (UDI-DI 05056190500436), active as of 22 Oct 2026. 5 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

5 closed

Documents

510(k) K123371

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05056190500436 UDI-DI Date23 Sep 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK123371 Date8 Jan 2013IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K123371 decided 8 Jan 2013 Active
  • FDA GUDID UDI-DI 05056190500436 listed 23 Sep 2021 Listed

Recalls

5 recalls · FDA

    • Terminated Z-0065-2019 FDA Class II initiated 24 Aug 2018

    RTInterface error in the event of an I/O error between the IGC PCB and the Framegrabber PCB

    • Terminated Z-2667-2016 FDA Class II initiated 30 Jun 2016

    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.

  • 2 recalls, same reason

    • Terminated Z-2150-2016 FDA Class II initiated 23 Jun 2016
    • Terminated Z-2149-2016 FDA Class II initiated 23 Jun 2016

    Varian Medical Systems has received reports that unintended changes were made to planned couch parameters, specifically the couch rotation parameter, during patient set-up. This can occur when a user sets a different couch rotation from the plan couch rotation while performing patient alignment with Optical Surface Monitoring System [OSMS].

    • Terminated Z-0464-2015 FDA Class II initiated 15 Oct 2014

    Potential failure of AlignRT to assert interlock.

Timeline

7 dated events

  1. Cleared FDA 510(k) K123371
  2. Recall initiated FDA recalls Z-0464-2015
  3. Recall initiated FDA recalls Z-2150-2016
  4. Recall initiated FDA recalls Z-2149-2016
  5. Recall initiated FDA recalls Z-2667-2016
  6. Recall initiated FDA recalls Z-0065-2019
  7. Listed FDA GUDID 05056190500436

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
AlignRT Plus
Generic name
Radiological video camera patient positioning/tracking system
Model / reference
Workstation Z2
Primary DI / UDI-DI
05056190500436
510(k) Number
FDA product code
IYE
GMDN term
Radiological video camera patient positioning/tracking system
Device class
Class II
Regulation number
892.5050
GUDID distribution status
In Commercial Distribution

Related devices

Category: Radiological video camera patient positioning/tracking system

Cleared under the same submission (K123371)

and 3 more cleared under K123371

Similar devices

Other devices filed under FDA product code IYE (Accelerator, Linear, Medical).

Other devices from Vision RT Limited

See all devices from Vision RT Limited →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)