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MEDTECH SAS recalls ROSA One 3.1 Brain application The device is intended for the spatial positioning and orientation of instruments hold
Recalled November 3, 2021 · FDA recall Z-0118-2022 · MEDTECH SAS
Hazard
The firm has become aware of a software anomaly affecting ROSA One 3.1 Brain application which led to the inaccurate placement of an electrode during surgery. The firm has received 3 global complaints related to the issue. An incorrect trajectory could result in serious injury or death if undetected during surgery. · FDA Class I
Units
119 (US); 55 (OUS)
Sold at
US Nationwide distribution and International Distribution to countries of: Australia, Taiwan, China, Thailand, Japan, India, South Korea, and the Netherlands.
Description
The firm has become aware of a software anomaly affecting ROSA One 3.1 Brain application which led to the inaccurate placement of an electrode during surgery. The firm has received 3 global complaints related to the issue. An incorrect trajectory could result in serious injury or death if undetected during surgery.
Product
ROSA One 3.1 Brain application The device is intended for the spatial positioning and orientation of instruments holders or tool guides to be used by trained surgeons to guide standard surgical instruments during brain and spine surgeries.
Manufacturer(s)
MEDTECH SAS
Made in
France
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →