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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 User Manual addendum, TORS for da Vinci Surgical System IS 1200, IS 2000 and IS 3000. Product Usage: The user manual for Transoral Surgery (TORS) provided information to update and replace the Indications for Use and Representative uses section and add the section Warnings for Transoral Otolaryngology Surgery.
Recall Number Z-1424-2013
Classification Class II
Code Info Model number 552002-01
Product Distributed Qty 1,374
Reason For Recall Change to User Manual to remove one indication for use and amend warnings to emphasize restrictions for use.

Event Detail

Event Id 65094
Product Type Devices
Status Terminated
Recalling Firm Intuitive Surgical, Inc.
City Sunnyvale
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-01-24
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern US Distribution Only