Medical Device Correction Notice
Zimmer Biomet is initiating a medical device correction for the ROSA One 3.1 Brain application products due to a software anomaly that may lead to incorrect placement of an electrode during surgery.
Affected Product
The affected product is the ROSA One 3.1 Brain application system, which is intended for spatial positioning and orientation of instruments holders or tool guides in neurosurgical procedures.
Description of the Issue
The software anomaly may occur when the device shuts down and is restarted, leading to an incorrect trajectory if the user chooses to “Clear the robotic arm” and performs an empty device calibration.
Required Actions
Users are advised to take immediate action to prevent incorrect instrument configuration by following a specific workaround procedure to avoid the issue.
Zimmer Biomet will deploy engineers to implement a new software version to correct the issue, estimated to begin in February 2022 and be completed by May 2022.
Manual:
Download: ROSA One 3.1 Brain Application User Manual
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