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Intuitive Surgical May Not Have Tested Devices Properly

Intuitive Surgical Inc., the maker of the da Vinci Surgical System robots, informed customers that 30 devices may not have been tested properly, according to the U.S. Food and Drug Administration.

The FDA, calling it a “class 2 recall,” said the action affects Intuitive’s da Vinci Si Vision System Cart, Si Surgeon Side Cart, Instrument Control Box and Dual Camera Controller, in notices posted on its website yesterday. Factory testing on the systems may not meet compliance standards, the regulator said. Intuitive sent the Urgent Device Correction notice to all affected customers on June 27, the FDA said.