A major medical device manufacturer has recalled a robotic medical surgical device due to software issues that could put patients’ lives at risk.
Issued by the device manufacturer Zimmer Biomet in September, the recall involves the company’s ROSA Brain robotic platform used to assist surgeons in positioning medical instruments or implants during a surgical procedure. A recent press release issued by the U.S. Food and Drug Administration (FDA) says that software integral to the operation of the robotic device can drive the robotic arm into an incorrect position, resulting in potential risk for a patient.
The FDA has classified Zimmer Biomet’s action related to the ROSA Brain device as a Class 1 recall, the most serious type of recall and reserved exclusively for instances in which the recalled device could cause serious injuries or death.
The recalled devices were distributed to medical surgical centers during an approximately three-year period, from April 2016 to March 2019. The recall reportedly involves a total of 86 ROSA brain devices distributed in the U.S.