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U.S. Department of Health and Human Services

Class 2 Device Recall Intuitive Surgical

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 Class 2 Recall
Intuitive Surgical
see related information
Date Posted September 17, 2008
Recall Status1 Terminated on March 25, 2011
Recall Number Z-1811-2008
Recall Event ID 48085
Premarket Notification
510(K) Number
Product Classification System,Surgical,Computer Controlled Instrument - Product Code NAY
Product INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODE; S Cardiac Probe Gasper Instrument, Model IS2000, Part Number 420215-02; Product is manufactured and distributed by Intuitive Surgical, Inc. Sunnyvale, CA . The IS2000 CPG is used during cardiac ablation procedures.
Code Information Lot Number: 802011
Recalling Firm/
Intuitive Surgical, Inc.
1266 Kifer Rd
Sunnyvale, California 94086-5304
Manufacturer Reason
for Recall
The product has a software interface problem. When the product is connected to the da Vinci IS2000 System it will not allow the System to recognize the Instrument which makes the IS2000 CPG instrument nonfunctional at all sites. Risks associated are loss of operability of the instrument, delay in surgery, and loss of dexterity.
FDA Determined
Cause 2
DESIGN: Software Design
Action On April 18, 2008 an Urgent Device Recall letter was issued to customers. Consignees were notified via e-mail and were instructed to return the product. Customers were instructed to segregate the product in a secure area for Intuitive Surgical CSRs. If you have any questions contact Karen Uyesugi at (408) 523-2100.
Quantity in Commerce 11
Distribution Class II Recall - Nationwide Distribution --- including states of NC, OH, GA and WI.
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.