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Zimmer Biomet is facing a Class I recall of its Rosa One Brain platform.
The system helps neurosurgeons position medical tools and implants during brain surgeries.
Devices ranging from biopsy needles to endoscopes to deep brain stimulation electrodes can be attached to the arm.
An error in the 3.1 version of the system’s software could cause those instruments to be incorrectly placed.
So far, only three complaints have been submitted in relation to the issue.
No deaths or injuries have been linked to the software error.
Zimmer Biomet first notified healthcare providers about the recall at the end of September.
Software error is triggered when the device is shut down either manually or unexpectedly, then rebooted and directed to recalibrate the robotic arm.
Corrective update expected to be ready for installation by February 2022.
Version 3.1 has been installed since December 2019 and has been used to perform approximately 3,600 brain surgeries.
The recall spans a total of 119 devices distributed across the U.S..
