FDA Recall

07/18/2013

da Vinci Robot Cited by FDA for Possible Inadequate Testing

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Audet and Partners, LLP, reports that the United States Food and Drug Administration ("FDA") has issued a Class 2 recall of 30 da Vinci systems.* The recall, issued to da Vinci's manufacturer, Intuitive Surgical on July 11, 2013, states that these systems may have been inadequately tested prior to deployment in hospitals and medical practices throughout the United States.* A spokeswoman for Intuitive Surgical stated in response to the recall notice that "one piece of equipment wasn't recording results properly."* A Class... Read More