FDA Says Intuitive May Have Failed to Test Some Da Vinci Robots
The United Stated Food and Drug Administration said Thursday that the robotic surgical device manufacturer Intuitive Surgical Inc. may have failed to test some of its da Vinci robotic surgical system equipment in accordance with acceptable factory testing standards.
According to the FDA, Intuitive has informed customers that 30 devices may not reached compliance standards; the agency has called the action a “class 2 recall” (“a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote”).
The action affects Intuitive da Vince Si Vision System, Si Surgeon Cart, Instrument Control Box and Dual Camera Controller. Intuitive send Urgent Device Correction notices to all affected customers on June 27th.
More information available at: Intuitive Surgical May Not Have Tested Devices Properly