| | Class 2 Recall
da Vinci S Surgical System IS2000 |  |
| Date Posted |
April 05, 2010 |
| Recall Number |
Z-1161-2010 |
| Product |
da Vinci S Surgical System IS2000 Endoscopic Instrument Control System, rev. A51_P7, manufactured by Intuitive Surgical, Sunnyvale, CA. |
| Code Information |
Code numbers between SG002 to SG836.
|
Recalling Firm/
Manufacturer |
Intuitive Surgical, Inc.
1266 Kifer Rd Bldg 100
Sunnyvale, California 94086-5304 |
| For Additional Information Contact |
Karen Vane
408-523-7228
|
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.
|
| 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. |
| |
|
|
|
|
