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U.S. Department of Health and Human Services

Enforcement Report - Week of July 17, 2013

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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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
da Vinci Instrument Control Box, model number ICB3000; 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. Part number 372012-96: Serial numbers: 323986 324198. Class II 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. 30 total, all devices Z-1689-2013
da Vinci Dual Camera Controller, model number DC3000; 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. Part number 372019-01: Serial numbers: 323943 323895 323882 323945 323994 323804 323979 323987 324042 324086. Class II 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. 30 total, all devices Z-1688-2013
da Vinci Si Vision System Cart, model number VS3000; 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. Part number 380990-11: Serial numbers: 324350 325289 325301 325858 325872 325686 325700 325639 325646 324537 324566 324087 324577 324772 324784 324948 325126 325279 325138 325621 325441 325453 325564 323865 323870 323977 324010 324014 324334. Class II 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. 30 total, all devices Z-1687-2013
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. 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 Class II 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. 30 total, all devices Z-1686-2013
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