FDA-Device2020-02-19Class II
ROSA Brain 3.0 Application-Brain
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.
Sold states
US Nationwide
Affected count
47 units
Manufactured in
900 Rue Du Mas De Verchant, Montpellier, France
Products
ROSA Brain 3.0 Application-Brain
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1150-2020Don't want to check this manually?
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