FDAnews
www.fdanews.com/articles/170780-intuitive-surgical-recalls-surgical-drapes

Intuitive Surgical Recalls Surgical Drapes

April 13, 2015

Intuitive Surgical is voluntarily recalling surgical drapes used with its da Vinci robot-assisted surgery system manufactured by Microtek Medical.

The Class II recall began March 16 when the Sunnyvale, Calif.-based company issued a field safety notice, informing consumers of a cloudy/waxy problem with an estimated 440,000 Mictrok drapes worldwide. The drapes are meant to be used in conjunction with the company’s da Vinci SI disposable accessory kit 3 ARM (5 pack).

The company signed a $430 million, five-year contract with the Department of Defense for the da Vinci device in March.

See the recall notice at www.fdanews.com/04-06-15-Class-2-Device.pdf. — Jason Scott