Intuitive Surgical, Inc. recalls IS3000 Vision Side Cart (VSC) used in conjunction with the da Vinci Si Surgical System IS3000. Product number 371683-05…

Recall date

December 5, 2014

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0940-2015

FDA classification

Class II

Brand / firm

Intuitive Surgical, Inc.

Sold / distributed

Worldwide Distribution: US (nationwide) and countries of: Belgium, France, Germany, Romania, India, Israel, Italy, South Korea, Norway, Slovak Republic, Spain, Sweden, Turkey, and United Kingdom.

Why it was recalled

Intuitive Surgical is initiating a voluntary correction related to da Vinci Si System (IS3000) Vision Side Carts, with threaded-in caster wheels, which can result in the caster wheel bolts gradually unthreading and the wheels loosening.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

IS3000 Vision Side Cart (VSC) used in conjunction with the da Vinci Si Surgical System IS3000. Product number 371683-05/Model Number VS3000 The Intuitive Surgical Endoscopic Instrument Control System (Intuitive Surgical da Vinci Surgical System Model IS3000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general cardiovascular and noncardiovascular thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures.