FDA issues serious recall for neurosurgery device often used alongside medical imaging
Healthcare providers and patients should be aware of a software issue that led the FDA to issue a recall for Zimmer Biomet’s ROSA One 3.1 Brain application.
The robotic platform is used, at times in conjunction with imaging, to assist neurosurgeons in positioning medical instruments during surgery. It contains a robotic arm that attaches to various surgical tools depending on the procedure,
The company recall states there is a software issue that could cause the device to shut down either manually or unexpectedly. After reboot, the programmed trajectory could be interrupted, which would cause the device to drive to an incorrect track. "If this occurs, it could cause adverse events such as stroke, serious injury, severe disability, and death," according to the statement sent out Tuesday.
In the U.S., a total of 119 of these devices distributed between December 1, 2019, and August 31, 2021, have been recalled. Zimmer Biomet initiated the recall on September 22, 2021.
As of today, no deaths have been reported in association with the recall.
For specific information regarding the recall, you can view the FDA’s announcement here.
In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She began covering the medical imaging industry for Innovate Healthcare in 2021.