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U.S. Department of Health and Human Services

Class 2 Device Recall Da Vinci S Surgical System

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 Class 2 Recall
Da Vinci S Surgical System
see related information
Date Posted March 29, 2007
Recall Status1 Terminated on December 05, 2007
Recall Number Z-0670-2007
Recall Event ID 37431
Premarket Notification
510(K) Number
K050369 
Product Classification System,Surgical,Computer Controlled Instrument - Product Code NAY
Product Intuitive brand Da Vinci S Surgical System, an Endoscopic Instrument Control System, Model SS2000 Patient Side Cart, Model PS2000, Part Number: 380267-01, IS2000, Top Level, 4-Arm; Distributed and Manufactured by: Intuitive Surgical, Inc. 950 Kifer Road Sunnyvale, CA
Code Information System Numbers: SG011, SG012, SG013, SG014, SG017, SG018, SG019, SG020, SG058, and SG094.
Recalling Firm/
Manufacturer
Intuitive Surgical, Inc.
950 Kifer Rd
Sunnyvale, California 94086-5206
Consumer Instructions Problem is exhibited on insertion. Device, after successful implantation, should perform as intended.
Manufacturer Reason
for Recall
Da Vinci S Surgical System's spinal pin could limit mechanical motion of the arm and render the system unavailable for surgical use, and may result in system failure and the need to convert to an alternative surgical technique.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action The firm did not release notification to its consignees. The reworks were arranged as part of routine service visits initiated on 4/12/06.
Quantity in Commerce 24 units
Distribution Nationwide.
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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