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Da Vinci Surgical Robot Update: FDA Issues Class 2 Recall of Intuitive Surgical’s da Vinci Robot due to Possibly Inadequate Testing of 30 Units, Notes Parker Waichman LLP
Date:7/15/2013

New York, NY (PRWEB) July 15, 2013

Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective medical devices, notes that, according to the U.S. Food and Drug Administration (FDA), Intuitive Surgical sent Urgent Device Correction notices to all affected customers on June 27 regarding the fact that 30 da Vinci surgical robots may not have been properly tested. Calling it a class 2 recall, the FDA issued a July 11 statement on its website noting that the affected parts are the da Vinci Si Vision System Cart, Si Surgeon Side Cart, Instrument Control Box and Dual Camera Controller.

The FDA added that factory testing on those four components "may not be in compliance with UL Standards” because one of the testing devices was malfunctioning.

“As the FDA noted, it is critical for medical device manufacturers to ensure they are compliant with all applicable regulations,” said William J. Dubanevich, attorney at Parker Waichman LLP. “What is of concern here is whether or not the potential failure to properly inspect the 30 subject surgical robots could have exposed surgical patients to an increased risk of surgical complication.”

Aggressive marketing by Intuitive and whether the company is providing adequate training are among other issues related to the da Vinci, the only surgical robot approved in the U.S. for soft-tissue surgery.

On March 14th, the American Congress of Obstetricians and Gynecologists (ACOG) issued a statement warning consumers not to let aggressive marketing oversh
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