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U.S. Department of Health and Human Services

Class 2 Device Recall da Vinci Si Vision System Cart

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 Class 2 Recall
da Vinci Si Vision System Cart
see related information
Date Posted July 11, 2013
Recall Status1 Terminated on January 22, 2014
Recall Number Z-1687-2013
Recall Event ID 65590
Premarket Notification
510(K) Number
K081137 
Product Classification System,Surgical,Computer Controlled Instrument - Product Code NAY
Product 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.
Code Information 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.
Recalling Firm/
Manufacturer
Intuitive Surgical, Inc.
1266 Kifer Rd Bldg 100
Sunnyvale, California 94086-5304
For Additional Information Contact Richard Reeves
408-523-2244
Manufacturer 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.
FDA Determined
Cause 2
DESIGN: Software Design
Action Intuitive Surgical sent an Urgent Device Correction notice dated July 15, 2013, to all affected customers by Federal Express.The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to ensure that all affected personnel were fully informed of the notification and that the notification should be forwarded to other managers within their facility. Customers were also instructed to complete and return the attached Acknowledgment Form to acknowledge receipt of the notification. Customers with questions were instructed to call Customer Service at 800-876-1310, Option 3. For questions regarding this recall call 408-523-2244.
Quantity in Commerce 30 total, all devices
Distribution Worldwide Distribution - USA including UT, CA, AZ, CO, FL, HI. MT, NY,TX and WA and one customer in Russia.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = NAY and Original Applicant = INTUITIVE SURGICAL, INC.
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