Class II recalls — a grade below the most serious Class I recalls — reference a situation in which the 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’s latest-generation surgical robot’s foot tray pedals were subject to an urgent medical device correction letter issued last month. The company warned customers of an increase in complaints concerning the foot tray pedal spring failing. This issue can result in the pedal remaining pressed.
[Intuitive is one of our 10 surgical robotics companies you need to know in 2025. For more on the wide world of surgical robotics, see our special report on the space.]
According to an FDA notice, 439 units of the affected surgical robot platform are currently in commerce. Intuitive sent customers a notification on Feb. 26 with instructions for the required actions to complete the device correction. It also instructs customers to inform Intuitive of any adverse events or quality problems through the standard process.
da Vinci 5, the surgical robotics leader’s newest robot, won FDA clearance a year ago, further cementing Intuitive’s place atop the space. The company rolled a limited launch in the U.S. into 2025 before a full commercial rollout. Features include new surgeon controllers and powerful vibration and tremor controls, leading the company to call da Vinci 5 its smoothest and most precise system to date.
Industry experts recently praised the launch of da Vinci 5 on the new season’s first DeviceTalks Tuesdays webinar as well.
