MEDTECH SAS recalls ROSA One 3.1 Brain application The device is intended for the spatial positioning and orientation of instruments holder…

Recall date

September 22, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0118-2022

FDA classification

Class I

Brand / firm

MEDTECH SAS

Sold / distributed

US Nationwide distribution and International Distribution to countries of: Australia, Taiwan, China, Thailand, Japan, India, South Korea, and the Netherlands.

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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.