According to an online news report published on medicaldevice-network.com, the U.S. Food and Drug Administration has announced a Class I recall of Zimmer’s ROSA One 3.1 Brain Application. The recall affected around 120 devices sold in the United States. Zimmer initiated the recall of the platform, indicating software problems. A Class I recall is the most serious of the three levels and warns consumers that the recalled product can cause injury and/or death.
Zimmer’s ROSA One 3.1 Brain Application was developed to help neurosurgeons perform brain surgeries more accurately by positioning the medical instruments or implants. The surgical system is comprised of a compact robotic arm and a touch screen for data input. Surgical instruments, including endoscopes, biopsy needles, recording or stimulation electrodes, are connected to the robotic arm to assist in the surgical procedure.
According to the FDA announcement, Zimmer Biomet announced the recall of its surgical robotic platform after finding a software anomaly that might prevent the accurate placement of surgical instruments, resulting in serious injuries, brain injuries, and even death.
So far, three issues with the brain surgical robotic platform have been reported to the issue. However, no reports of injuries or deaths have been reported at this time. Zimmer Biomet has recalled the devices that were distributed between December 1, 2019, and August 31, 2021. Zimmer Biomet affirmed that its Total Knee, Partial Knee, ROSA Spine, and Hip application systems do not have the software error.
The FDA announced that the recall would affect health care providers who are using the recalled ROSA One 3.1 Brain Application as well as patients who are scheduled for operations that would have used the application.
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