Vision Rt Inc recalls AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a pat…

Recall date

November 11, 2014

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0934-2015

FDA classification

Class II

Brand / firm

Vision Rt Inc

Sold / distributed

Nationwide Distribution

Why it was recalled

Potential use error when the external Gate Controller is turned ON after the Vision RT software has been opened.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.