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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
Intuitive Surgical 		see related information
Date Posted September 17, 2008
Recall Number Z-1811-2008
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/
Manufacturer		 Intuitive Surgical, Inc.
1266 Kifer Rd
Sunnyvale, California 94086-5304
Consumer Instructions Contact the recalling firm for information
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.
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.
 
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