Intuitive Surgical, Inc. recalls da Vinci Si Surgical System, IS3000; - Wall chart for EndoWrist Stapler 45 System. Intended to assist in the accurate c…

Recall date

January 15, 2015

Source

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

Recall number

Z-1048-2015

FDA classification

Class II

Brand / firm

Intuitive Surgical, Inc.

Sold / distributed

Nationwide Distribution

Why it was recalled

The Wall chart has been updated because it was noted that Wall Chart (PN 551524-03 Rev A) was inconsistent with the User Manual Adendum (PN 550986-07_B) with regards to neceassary sterilization dry time.

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; - Wall chart for EndoWrist Stapler 45 System. Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.