Z-1180-2008

da Vinci S Surgical System, Model number IS2000 Revision number A51 P5; endoscopic surgical control system...

Name: Z-1180-2008 da Vinci S Surgical System, Model number IS2000 Revision number A51 P5; endoscopic surgical control system...
Creator: Intuitive Surgical, Inc.
Published: 2007-12-27
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2007-12-27 / Terminated / root cause: software

FDA source

Intuitive Surgical, Inc. began a recall of da Vinci S Surgical System, Model number IS2000 Revision number A51 P5; endoscopic surgical control system, Intuitive Surgical, Inc., Sunnyvale, CA 94086 on 2007-12-27. The reason FDA records is "Delay in responding: In certain circumstances, the device may not respond immediately to a user's command such as master clutch or camera control". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1180-2008
Status: Terminated
Initiated: 2007-12-27
Posted: 2008-06-12
Terminated: 2008-08-15
Recalling firm: Intuitive Surgical, Inc.
Product: da Vinci S Surgical System, Model number IS2000 Revision number A51 P5; endoscopic surgical control system, Intuitive Surgical, Inc., Sunnyvale, CA 94086
Product code: NAY System, Surgical, Computer Controlled Instrument
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.
Root cause tag: software
FDA root cause: Software design
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
Product codes and lots: 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

Product code NAY

K050369Class IIIntuitive Surgical Da Vinci Surgical System, Model Is2000Intuitive Surgical, Inc. / cleared 2005-04-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)