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U.S. Department of Health and Human Services

Enforcement Report - Week of April 24, 2013

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Product Detail

Product Description IS3000 USER MANUAL for Intuitive Surgical da Vinci Si Surgical System and da Vinci Si-e Surgical System, Model SI3000. Arm drapes protect equipment from contamination.
Recall Number Z-1110-2013
Classification Class II
Code Info Model number 550650-05 (P8)
Product Distributed Qty 1642 customers
Reason For Recall Revised instructions for users of the da Vinci S, Si and Si-e systems with additional information regarding sterile adapter engagement and instrument installation.

Event Detail

Event Id 64755
Product Type Devices
Status Ongoing
Recalling Firm Intuitive Surgical, Inc.
City Sunnyvale
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-03-15
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution.-USA (nationwide) and countries of: Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Netherlands, Norway, South Korea, Sweden, Switzerland, and United Kingdom.
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