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U.S. Department of Health and Human Services

Enforcement Report - Week of June 5, 2013

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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

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Model number 552002-01 Class II Change to User Manual to remove one indication for use and amend warnings to emphasize restrictions for use. 1,374 Z-1424-2013
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