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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 Device Recall da Vinci S Surgical System see related information
Date Initiated by Firm October 04, 2007
Date Posted February 22, 2008
Recall Status1 Terminated 3 on March 31, 2011
Recall Number Z-0152-2008
Recall Event ID 45518
510(K)Number K990144  K021036  K050369  K063220  
Product Classification Surgical Computer Controlled Instrument System - Product Code NAY
Product Intuitive brand da Vinci S Surgical System, Endoscopic Instrument Control System, Model IS2000 with Isolation Transformer (P/N: 952012) and Vision Cart (Model: VS2000), Distributed and Manufactured by: Intuitive Surgical, Inc. 950 Kifer Road Sunnyvale, CA
Code Information SG015, SG053, SG060, SG067, SG096, SG126, SG151, SG164, SG201, SG245, SG267, SG269, SG270, SG271, SG272, SG273, SG275, SG276, SG278, SG280, SG282, SG283, SG285, SG286, SG287, SG288, SG289, SG290, SG291, SG292, SG293, SG294, SG295, SG296, SG297, SG298, SG299, SG300, SG301, SG302, SG303, SG309, SG312, SG313, SG314, SG315, SG316, SG317, SG318, SG319, SG323, SG324, SG325, SG326, SG329, and SG330 
Recalling Firm/
Manufacturer		 Intuitive Surgical, Inc.
950 Kifer Rd
Sunnyvale CA 94086-5206
For Additional Information Contact
408-523-2100
Manufacturer Reason
for Recall		 Under-Rated Fuses -- The Firm may have installed incorrect fuses. The daVinci Surgical System Vision Cart's isolation transformer requires a 10A fuse for 115V operation or a 5A fuse for 230V operation. Operation of this product with the use of an under-rated fuse will result in failure of the fuse and a loss of power to the vision cart, including the loss of power to any ancillary equipment that
FDA Determined
Cause 2		 Mixed-up of materials/components
Action A product recall was initiated on October 4, 2007. Direct and Distributor consignees were sent an Important Product Notice, via electronic mail on October 5, 2007. The firm plans on sending a Field Service Engineer to inspect the system and make any necessary corrections.
Quantity in Commerce 63 total units
Distribution Worldwide Distribution --- USA including states of AL, AR, AZ, CA, CO, CT, DE, FL, IL, IN, KS, LA, MA, MD, MN, NC, NJ, NV, OH, PA, PR, SD, TN, TX, WA, and WI, and countries of Belgium, Ireland, Italy, Korea, Russia, and the United Kingdom.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NAY and Original Applicant = INTUITIVE SURGICAL, INC.
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