Home / Recalls / Medical Devices
MEDTECH SAS recalls ROSA Brain 3.0 Application-Brain
Recalled February 19, 2020 · FDA recall Z-1150-2020 · MEDTECH SAS
Hazard
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. · FDA Class II
Units
47 units
Sold at
US Nationwide
Description
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.
Product
ROSA Brain 3.0 Application-Brain
Manufacturer(s)
MEDTECH SAS
Made in
France
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →