Zimmer Biomet is recalling the ROSA One 3.1 Brain Application due to a software error that could lead to incorrect placement of instruments during stereotactic neurosurgical procedures.
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.
Zimmer Biomet is recalling this product due to a software error that could lead to incorrect placement of instruments during stereotactic neurosurgical procedures (for example, techniques to direct the tip of a tool using coordinates provided by medical imaging to reach a specific part of the brain). If this error occurs, it could cause adverse events such as stroke, serious injury, severe disability, and death.
There have been three complaints about this device issue and no deaths or injuries reported about this device issue as of yet.
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.
