da Vinci S Surgical System IS2000 Endoscopic Instrument Control System, rev. A51_P7, manufactured by Intuitive Surgical, Sunnyvale, CA.
Recall
- Recall Number
- Z-1161-2010
- Event Number
- 53214
- Firm
- Intuitive Surgical, Inc.
- FEI Number
- 3001675293
- Product Code
- NAY
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- July 15, 2009
- Posted
- April 5, 2010
- Terminated
- February 11, 2011
- Address
- 1266 Kifer Rd, Bldg 100, Sunnyvale, CA, 94086-5304
Description
da Vinci S Surgical System IS2000 Endoscopic Instrument Control System, rev. A51_P7, manufactured by Intuitive Surgical, Sunnyvale, CA.
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.
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.
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.
782 units