Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant Recalled by Vision RT Ltd Due to RTInterface error in the event of an I/O...

Date: August 24, 2018
Company: Vision RT Ltd
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Vision RT Ltd directly.

Affected Products

Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant only. The AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment. Part number: V000172

Quantity: 690 systens

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Vision RT Ltd

Vision RT Ltd has 4 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report