FDA recall Z-1151-2020

Product

ROSA One 3.1 Brain Application

Reason for recall

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.

Distribution

US Nationwide

Key facts

Status

Terminated

Initiation date

2020-01-06

Report date

2020-02-19

Termination date

2020-11-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Montpellier, France

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1151-2020