Z-1161-2010

da Vinci S Surgical System IS2000 Endoscopic Instrument Control System, rev. A51_P7, manufactured by...

Name: Z-1161-2010 da Vinci S Surgical System IS2000 Endoscopic Instrument Control System, rev. A51_P7, manufactured by...
Creator: Intuitive Surgical, Inc.
Published: 2009-07-15
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2009-07-15 / Terminated / root cause: software

FDA source

Intuitive Surgical, Inc. began a recall of da Vinci S Surgical System IS2000 Endoscopic Instrument Control System, rev. A51_P7, manufactured by Intuitive Surgical, Sunnyvale, CA on 2009-07-15. The reason FDA records is "Gripper or Scissor jaws may close inadvertently, and will not open on command and various other reported modes of failure. Control by surgeon may fail and this failure may be difficult to detect". 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-1161-2010
Status: Terminated
Initiated: 2009-07-15
Posted: 2010-04-05
Terminated: 2011-02-11
Recalling firm: Intuitive Surgical, Inc.
Product: da Vinci S Surgical System IS2000 Endoscopic Instrument Control System, rev. A51_P7, manufactured by Intuitive Surgical, Sunnyvale, CA.
Product code: NAY System, Surgical, Computer Controlled Instrument
Reason for recall: Gripper or Scissor jaws may close inadvertently, and will not open on command and various other reported modes of failure. Control by surgeon may fail and this failure may be difficult to detect.
Root cause tag: software
FDA root cause: Software design
Action: Recall initiated the recall on July 1, 2009. US consignee recall was initiated on July 7, 2009. All affected consignees have been notified via e-mail communication followed by a field service engineer visit. Customers with questions or with need for additional assistance regarding the notification, please contact the firm's Intuitive Surgical Customer Service Department at 1-800-876-1310 toll free.
Quantity in commerce: 782 units
Distribution: Product was distributed to 551 consignees throughout the US to AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI, WV AND WY, as well as to Puerto Rico, and to Austria, Belgium, Bulgaria, Czech Republic, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Netherlands, Norway,Qatar, Romania, Spain, Sweden, Switzerland, Turkey, the United Kingdom, Argentina, Australia, Brazil, Canada, China, India, Israel, Japan, Korea, Mexico, Russia, Saudi Arabia, Singapore and South Korea.
Product codes and lots: Code numbers between SG002 to SG836.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)