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SUNNYVALE, Calif. — Intuitive Surgical, maker of a $1.5 million robot surgery system, told doctors that friction in the arms of some devices may cause the units to stall, the second warning issued about the company’s products in a month.
The company sent an “urgent medical device recall” Nov. 11 alerting customers of the issue, which affects 1,386 of the systems worldwide, the Food and Drug Administration said in a Tuesday notice on its website. The stalling may result in a sudden “catch-up” if the surgeon pushes through the resistance, the agency said.
Intuitive is facing growing questions about its marketing strategies, training procedures and the safety of its devices, Bloomberg News has reported.
