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FDAFDA · Food and drugs·Recall number Z-0139-2014

Patient Cart used in conjunction with the da Vinci S surgical and SI System. Intuitive Surgical 1266 Kifer Road Sunnyvale, CA 94086 The Patient Side Cart (PSC) is a robotic platform used for da Vinci Surgery. It is the operative component for both da Vinci systems and its primary function is to support he instrument arms and camera arm. It uses remote center technology. The remote center is a fixed point in space around which the Patient Cart arms move. Remote center technology enables the system to maneuver instruments and endoscopes in the surgical site while exerting minimal force on the patient body wall. The Patient Cart works in the sterile field, assisting the Surgeon Console operator by exchanging instruments and endoscopes, and by performing other patient-side activities. To help ensure patient safety, the action of the Patient Cart operator take precedence over actions of the Surgeon Console operator.

Published November 13, 2013 · Recall initiated: December 11, 1930

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Increased number of complaints regarding fluid entering the patient card base of the da Vinci S and SI systems.

What to do

Voluntary: Firm initiated · Visit

Recall details

Manufacturer
Intuitive Surgical, Inc.
Distributor
Worldwide Distribution - USA including Puerto Rico and the countries of Australia, Austria, Argentina, Belgium, Bulgaria, Brazil, Canada, Chile, China, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, India, Indonesia, Ireland, Israel, Japan, Kuwait, Mexico, Netherlands, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Uruguay and Venezuela.
Lot
Model IS2000 and IS 3000
Risk classification
Class II
Area (FDA)
device
Country
United States

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