Class II recalls denote "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," according to the federal watchdog agency.
The FDA said factory testing on 4 components of the da Vinci device – the da Vinci dual camera controller, da Vinci instrument control box, da Vinci Si surgeon side cart and da Vinci Si vision system cart – "may not be in compliance with UL Standards as 1 of the testing devices was found to be working incorrectly," according to notices posted on the agency’s website.
Sunnyvale, Calif.-based Intuitive sent an "urgent device correction" notice to all affected customers June 27, according to the FDA.
"The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to ensure that all affected personnel were fully informed of the notification and that the notification should be forwarded to other managers within their facility. Customers were also instructed to complete and return the attached Acknowledgment Form to acknowledge receipt of the notification," according to the agency.
"We discovered that 1 piece of testing equipment wasn’t recording results properly," Angela Wonson, an Intuitive spokeswoman, told Bloomberg in an e-mailed statement, adding that "all systems have passed" field testing and that no complaints were received.
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston.