Software glitches have been at the root of several medical device recalls in recent years as medtech continues to embrace connectivity. The latest example of this trend is Zimmer Biomet's recall of the Rosa One 3.1 Brain Application.
FDA recently flagged the recall, which was initiated in late September. The agency said a software problem could lead to the incorrect placement of instruments during stereotactice brain procedures performed with the company's robotic platform. Two years ago, Zimmer Biomet also had to issue a recall related to a software problem involving the robotic brain surgery platform. The earlier software problem incorrectly positioned the robotic arm of the Rosa Brain 3.0 system.
FDA said there have been three complaints about the current Rosa software issue, but no deaths or injuries have been reported. Specific instructions for hospital staff and surgeons who use the robot can be found here.
Software has long been cited as the top reason for medical device recalls.
So far in 2021, software errors have been the root cause of four of the 53 class I medical device recalls that FDA has posted. Other companies that have had software-related recalls this year include Abbott, Baxter, and Vero Biotech.
In 2020, software-related problems were cited as the reason behind four of the 33 class I medical device recalls that FDA posted. In 2019, MD+DI reported at least six software-related medical device recalls out of 48 recalls that year.
Given the industry's increased reliance on artificial intelligence and the rise of digital health, it might seem surprising that there hasn't been more medical device recalls linked to software errors. But advancements in software and AI-based technologies also offer numerous benefits to the medical device industry. AI can even help companies prevent medical device recalls by predicting quality problems before they happen, as described in this article that MD+DI recently published.