FDA classifies Intuitive Surgical recall as class 2

The FDA has classified an Intuitive Surgical recall of its da Vinci SP robotic surgery systems as class 2, the agency reported June 3. The recall was initiated by Intuitive Surgial in April 2019 after it discovered the system could trigger a vibration of the instrument tips and endoscope due to a "software anomaly."

A class 2 recall is defined as "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."

Intuitive said the vibration only occurs in "extremely rare" situations and didn't specify risks the mechanical vibration poses for patients. 

Read the FDA's recall notice here

Copyright © 2022 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.

 

Featured Whitepapers

Featured Webinars