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MEDTECH SAS recalls ROSA One 3.1 Brain Application
Recalled February 19, 2020 · FDA recall Z-1151-2020 · 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
39 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 One 3.1 Brain Application
Manufacturer(s)
MEDTECH SAS
Made in
France
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →