MEDTECH SAS recalls ROSA One 3.1 Brain Application

Recall date

January 6, 2020

Source

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

Recall number

Z-1151-2020

FDA classification

Class II

Brand / firm

MEDTECH SAS

Sold / distributed

US Nationwide

Why it was recalled

Some cross-sectional images from the image acquisitions of the patients head may not be reconstructed/displayed properly in two and three dimension views when using ROSA Brain software, potentially compromising the surgery planning.

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

What was recalled

ROSA One 3.1 Brain Application