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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls

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 Class 2 Recall
da Vinci S Surgical System
see related information
Date Posted June 12, 2008
Recall Number Z-1180-2008
Product da Vinci S Surgical System, Model number IS2000 Revision number A51 P5; endoscopic surgical control system, Intuitive Surgical, Inc., Sunnyvale, CA 94086
Code Information Model number IS2000, Revision AP51 P5, System numbers SG015, SG020, SG040, SG103, SG152, SG169, SG179, SG213, SG215, SG355, top level part numbers 380267-01, 380431-02, and 380431-05
Recalling Firm/
Manufacturer
Intuitive Surgical, Inc.
950 Kifer Rd
Sunnyvale, California 94086-5206
Reason for
Recall
Delay in responding: In certain circumstances, the device may not respond immediately to a user's command such as master clutch or camera control.
Action Beginning 12/28/2007, Intuitive Surgical Field Service Representatives visited each site to correct the issues. A notification letter was provided to all sites.
Quantity in Commerce 9 units
Distribution USA Distribution: TX, NJ, WA, NV, HI, MI, NH and CA
 
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