A software error has prompted a Class I recall of the Zimmer Biomet Rosa One Brain platform, a robotic system that helps neurosurgeons position tools and implants during brain surgery. The company first notified customers about the recall at the end of September.
Devices ranging from biopsy needles to endoscopes to deep brain stimulation electrodes can be attached to the end of the Rosa One arm and programmed to perform minimally invasive procedures.
According to the FDA’s recall notice, an error in the 3.1 version of the system’s software could cause those instruments to be incorrectly placed during stereotactic neurosurgeries. For example, the agency said, coordinates entered into the system to send a tool to a specific location in the brain could be misinterpreted, sending the tool to the wrong area and potentially leading to stroke, serious injury, severe disability or death.
So far, only three complaints have been submitted in relation to the issue, with no deaths or injuries linked to the software error. One of the complaints came after the system inaccurately placed an electrode on the brain during a surgical procedure.
Read the article in its entirety at Fierce Biotech.