da Vinci Si Surgeon Console. Intended to assist in the accurate Control of Intuitive Surgical ...
FDA Recall #Z-1429-2013 — Class II — September 19, 2011
Product Description
da Vinci Si Surgeon Console. Intended to assist in the accurate Control of Intuitive Surgical Endoscopic Instruments.
Reason for Recall
Clarification of existing labeling information and operating procedures.
Recalling Firm
Intuitive Surgical, Inc. — Sunnyvale, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
NA
Distribution
Worldwide Distribution- USA Nationwide and countries of: Argentina, Australia,Canada, Chile, China, Czech Republic, Egypt, India, Israel, Italy,Korea-Republic of, Poland, Qatar, Romania, Saudi Arabia, Singapore, Spain, Thailand, Turkey, and Venezuela.
Code Information
Model number: 314850, versions 1-6
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated