FDA Medical Device Recalls (openFDA)
Intuitive Surgical, Inc.: da Vinci S Surgical System IS2000 Endoscopic Instrument Control System, rev. A51_P7, manufactured by Intuitive Surgical, Sunnyvale, CA.
- Recall number
- Z-1161-2010
- 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.
- Status
- Terminated
- Initiated
- 2009-07-15
- Posted
- 2010-04-05
- Terminated
- 2011-02-11
- Reason
- 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
- 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
- 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.
- Lot, serial or model codes
- Code numbers between SG002 to SG836.
- 510(k) numbers
- ["K050369"]
- PMA numbers
- not on file
- Product code
- NAY
- Firm FEI
- 3001675293
- Firm city
- Sunnyvale
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28