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U.S. Department of Health and Human Services

Enforcement Report - Week of June 5, 2013

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Product Detail

Product Description da Vinci Si Surgeon Console. Intended to assist in the accurate Control of Intuitive Surgical Endoscopic Instruments.
Recall Number Z-1429-2013
Classification Class II
Code Info Model number: 314850, versions 1-6
Product Distributed Qty NA
Reason For Recall Clarification of existing labeling information and operating procedures.

Event Detail

Event Id 65083
Product Type Devices
Status Terminated
Recalling Firm Intuitive Surgical, Inc.
City Sunnyvale
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2011-09-19
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern 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.