Intuitive Surgical, Inc. recalls da Vinci Si Surgical System IS3000, Monitor Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a…

Recall date

March 16, 2015

Source

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

Recall number

Z-1386-2015

FDA classification

Class II

Brand / firm

Intuitive Surgical, Inc.

Sold / distributed

Worldwide Distribution-Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China (including Hong Kong), Colombia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, France, Germany, Greece, Iceland, India, Indonesia, Ireland, Israel, Italy, Ja…

Why it was recalled

Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.

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

What was recalled

da Vinci Si Surgical System IS3000, Monitor Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.