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U.S. Department of Health and Human Services

Enforcement Report - Week of July 17, 2013

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Product Detail

Product Description da Vinci Si Surgeon Side Cart, model number SS3000; Manufactured by Intuitive Surgical, Sunnyvale, CA 94086. Intuitive Surgical endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments. It is intended for adult and pediatric use.
Recall Number Z-1686-2013
Classification Class II
Code Info Part number 380610-15: Serial numbers: 323936 323937 325082 325143 325175 325178 325355 325290 325352 325669 325672 325692 325444 325446 325447 325583 325585 325587 325634 325671 325684 325720 325724 325719 325888 325465 325549 325266 325268 323875 324092 324098 324100 324190 324258 324260 324265 324370 324425 324426 324528 324585 324586 324638 324649 324847 324848 324849 325076
Product Distributed Qty 30 total, all devices
Reason For Recall Factory testing on da Vinci Si Surgical Systems may not be in compliance with UL Standards as one of the testing devices was found to be working incorrectly.

Event Detail

Event Id 65590
Product Type Devices
Status Ongoing
Recalling Firm Intuitive Surgical, Inc.
City Sunnyvale
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-06-08
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - USA including UT, CA, AZ, CO, FL, HI. MT, NY,TX and WA and one customer in Russia.
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