Agency classClass IIOur severity:High FDA (Devices)·Z-2667-2016·Announced 2016-08-31

Vision RT AlignRT Plus System Recalled for Unintended Couch Parameter Changes

Vision RT Ltd is recalling 47 AlignRT Plus systems because unintended changes to couch rotation parameters were discovered during patient set-up. No patient harm was reported.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a high-risk medical device (radiation therapy) where a defect could lead to harm, but the source explicitly states that no patient harm or serious injury was reported in the identified cases, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Vision RT Ltd is recalling 47 units of the AlignRT Plus system (private label-OSMS, model K123371). The device is indicated for use to position and monitor patients relative to the prescribed treatment isocentre and to automatically withhold the beam during radiation delivery. The recall was initiated after the manufacturer received three reports from different sites indicating that unintended changes were made to planned couch parameters, specifically the couch rotation parameter, during patient set-up.

The affected units were distributed in the United States, Canada, Germany, Japan, Sweden, Switzerland, Taiwan, and the United Kingdom. No product was distributed to US government accounts. The specific serial numbers of the affected devices are listed in the official recall notice.

No patient harm or serious injury was reported in any of the three cases that triggered the recall. The agency classification for this recall is Class II. Users of the affected devices should contact Vision RT Ltd for further instructions regarding the recall and corrective actions.

The recalled product

Product: AlignRT¿ Plus [private label-OSMS] K123371: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to withhold the beam automatically during radiation delivery.
Manufacturer: Vision RT Ltd
Category: Medical Device — Radiation Therapy Equipment
Hazard: device-malfunction
incorrect-positioning
Affected units: 47

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 recalled by Vision RT Ltd under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Vision RT Ltd

See all →

Low
Laser tracking system recalled over laser information omitted from instructions
FDA (Devices) · 2026-01-14
High
Vision RT AlignRT Plus Integrated Gate Controller PCB Recall
FDA (Devices) · 2018-10-10
High
Vision RT TrueBeam and Edge Radiotherapy Systems Recalled for Parameter Errors
FDA (Devices) · 2016-08-31

Same hazard · device malfunction