da Vinci Si Surgical System IS3000 with the da Vinci Surgeon Console which contains a high Resolu...
FDA Recall #Z-0088-2014 — Class II — October 17, 2011
Product Description
da Vinci Si Surgical System IS3000 with the da Vinci Surgeon Console which contains a high Resolution Stereoscopic Viewer. Intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments.
Reason for Recall
Improper restraints during transportation of the da Vinci system could cause the HRSV Monitor to become loose from its mount.
Recalling Firm
Intuitive Surgical, Inc. — Sunnyvale, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
1,090 consoles
Distribution
Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Austria, Belgium, Canada, Chile, China, Denmark, Egypt, Finland, France, Greece, Germany, India, Indonesia, Israel, Ireland, Italy, Kuwait, Mexico, Netherlands, Norway, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, and United Kingdom.
Code Information
model numbers 380610-04 through 38-610-14.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated