Zimmer Biomet (NYSE:ZBH) today issued a voluntary medical device field action for its Rosa Brain, Rosa Spine and Rosa One surgical robotic platforms over movement issues with the systems’ robotic arms.
The company said that a situation can occur where the robot arm’s position is automatically sent to the trajectory input due to an imperfect mathematical model that could prevent the arm from reaching its desired position.
If the error occurs during isocentric micromoves used in brain surgeries while instrumentation is already in place inside the patient’s anatomy, the company warned that a hazardous situation could occur. Possible results could be ineffective treatment, serious injury or even death, according to an urgent medical device notice.
During other procedures, the company warned that the issue could lead to a displayed error on the system and a delay in surgery.
No customer reports of the issue have been received, according to the company.
Warsaw, Ind.-based Zimmer Biomet instructed any users to discontinue the use of micromovement functions in iso centric mode during brain surgeries with its Rosa Brain 3.0 and Rosa one devices.
The company said that it is preparing a software patch to correct the issue, with a slated release date of August 2017.