A class-2 recall is not as serious as a class-1. However, it does indicate there is some possibility of adverse health consequences when using the product in question.
(PRWEB) July 12, 2013
Da Vinci surgical robot maker Intuitive Surgical has initiated a class-2 recall of 30 devices it said might not have been properly tested, according to a July 12, 2013 Bloomberg story.* The Rottenstein Law Group LLP, which represents clients in da Vinci surgical robot lawsuits, notes that this is one of several announcements from the U.S. Food and Drug Administration this year regarding the da Vinci.
The FDA said in the story that factory testing on the systems might not meet safety compliance standards, and referred to the recall as a “class-2 recall.” Intuitive sent a warning letter to customers on June 27 indicating that some factory testing equipment might not have been functioning properly. The recall affects the da Vinci Si Vision System Cart, Si Surgeon Side Cart, Instrument Control Box and Dual Camera Controller.
“A class-2 recall is not as serious as a class-1,” said Rochelle Rottenstein, principal of the Rottenstein Law Group LLP. “However, it does indicate there is some possibility of adverse health consequences when using the product in question.”
The FDA has been surveying doctors in the United States to determine the safety of the da Vinci surgical robot in light of an increase in adverse event reports. According to Bloomberg, there were 70 deaths in 2009 indirectly attributed to the device.
According to a USA Today article, the da Vinci surgical robot was used in about 400,000 surgeries in 2012.** In May 2013 Intuitive defeated a negligent training claim in court (Estate of Fred E. Taylor v. Intuitive Surgical Inc.; 09-2-03136-5, Superior Court, Port Orchard, Wash.). Intuitive Surgical asserts that it is fully committed to superior training opportunities for surgeons and surgical teams in the use of its products, but notes that it does not participate in determining when a surgeon is adequately prepared to operate using the da Vinci Surgical System.
The Rottenstein Law Group LLP encourages people to visit its website to download a free brochure to help them determine if they are eligible to file a da Vinci lawsuit, and to learn more about the device and its alleged adverse side effects.
**usatoday.com/story/news/nation/2013/04/09/robot-surgery-fda/2067629/ (April 9, 2013)
About THE ROTTENSTEIN LAW GROUP LLP
The Rottenstein Law Group LLP is a New York-based firm that represents clients nationwide in mass tort actions. The firm was founded by Rochelle Rottenstein, who has more than two decades of experience as a lawyer, to represent clients hurt by defective medical devices and medications. (Attorney advertising. Prior results do not guarantee a similar outcome.)
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