FDA Announces da Vinci Surgical System Robot Recall

According to Bloomberg News, Intuitive Surgical Inc. (ISRG), which makes da Vinci Surgical System robots, informed the U.S. Food and Drug Administration last month that 30 devices may not have been tested properly, leading to a recall.

The FDA said that the class 2 recall affects Intuitive’s da Vinci Si Vision System Cart, Si Surgeon Side Cart, Instrument Control Box and Dual Camera Controller models. According to the FDA, factory settings for the devices may not meet compliance standards.

“We discovered that one piece of testing equipment wasn’t recording results properly,” Angela Wonson, an Intuitive spokesperson said in a statement. Wonson said that the company retested the 30 devices in the field and that they passed standards.

In February, Bloomberg reported that regulators were going to begin surveying surgeons about da Vinci robots after a “rise in adverse event reports that include as many as 70 deaths since 2009.”

While advancements in surgical technology have reduced human error, robotic programs and processes should be adopted slowly, until there is no question about safety. There needs to be strong oversight when it comes to robotic technology provided by medical care providers and manufacturers to avoid adverse events during procedures.

Contact our injury lawyers if you have experienced negative side effects or had a family member killed because of a dangerous or defective medical device. Our firm offers confidential, no obligation consultations.