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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 Systemsee related information
Date Initiated by FirmOctober 04, 2007
Date PostedFebruary 22, 2008
Recall Status1 Terminated 3 on March 31, 2011
Recall NumberZ-0152-2008
Recall Event ID 45518
510(K)NumberK021036 K050369 K063220 K990144 
Product Classification Surgical Computer Controlled Instrument System - Product Code NAY
ProductIntuitive 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
ActionA 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 Commerce63 total units
DistributionWorldwide 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 CycleTPLC 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) Database510(K)s with Product Code = NAY
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