The Food and Drug Administration (FDA) has announced a recall of the ROSA One 3.1 Brain Application (Zimmer Biomet) due to a software error that could lead to incorrect placement of instruments during stereotactic neurosurgical procedures. If this occurs, it could cause adverse events such as stroke, serious injury, severe disability, and death. 

The ROSA One 3.1 Brain Application is a robotic platform that helps neurosurgeons with positioning medical instruments or implants during surgery. The device is composed of a compact robotic arm and a touch screen mounted on a stand. Different types of instruments or tools (for example, biopsy needles, stimulation or recording electrodes, endoscopes) may be attached to the end of the robotic arm, depending on the surgical procedure.

There have been 3 complaints about this device issue. There have been no deaths or injuries reported about this device issue. The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Food and Drug Administration (FDA). Zimmer Biomet Recalls ROSA One 3.1 Brain Application Due to Error in Software. October 29, 2021. Available at: click here. Accessed November 1, 2021.