—#68034

Product

da Vinci S Surgical System, Model number IS2000 Revision number A51 P5; endoscopic surgical control system, Intuitive Surgical, Inc., Sunnyvale, CA 94086

FDA product code: NAY — System, Surgical, Computer Controlled Instrument
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K050369
Affected lot / code info: 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

Why it was recalled

Delay in responding: In certain circumstances, the device may not respond immediately to a user's command such as master clutch or camera control.

Root cause (FDA determination)

Software design

Action the firm took

Beginning 12/28/2007, Intuitive Surgical Field Service Representatives visited each site to correct the issues. A notification letter was provided to all sites.

Recalling firm

Firm: Intuitive Surgical, Inc.
Address: 950 Kifer Rd, Sunnyvale, California 94086-5206

Distribution

Distribution pattern: USA Distribution: TX, NJ, WA, NV, HI, MI, NH and CA

Timeline

Recall initiated: 2007-12-27
Posted by FDA: 2008-06-12
Terminated: 2008-08-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #68034. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.