Zimmer Biomet Recalls Rosa One Brain App

Zimmer Biomet has recalled its Rosa One 3.1 Brain Application, a robotic platform that helps neurosurgeons with positioning medical instruments or implants during surgery, due to a software error. The device comprises a compact robotic arm and a touch screen mounted on a stand. Different types of instruments or tools (biopsy needles, stimulation or recording electrodes, endoscopes) may be attached to the end of the robotic arm, depending on the surgical procedure.

According to a recall notice, the software error 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 occurs, it could cause adverse events such as stroke, serious injury, severe disability, and death.” The notice says there have been three complaints about the device issue.