Recall Z-2204-2008 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
da Vinci S Surgical System, Model number IS2000 Endoscopic Instrument Control System, manufactured by Intuitive Surgical, Sunnyvale, CA.
| Date | Sep 16, 2008 (initiated Jun 1, 2008) |
| Status | Terminated |
| Reason | Defective software chip may cause the system to fail and lock up. |
| Root cause | Software design (manufacturing process) |
| Action | Recall initiated June 1, 2008. Urgent Device Recall Letters were sent via e-mail, with follow up phone calls and service visits to correct the product. The firm recommended that continued use of the da Vinci S Surgical System during the time period prior to our service update to replace the software chip. The letter emphasizes the importance of always having backup equipment and instrumentation available when performing surgery with the da Vinci S Surgical System and being prepared to convert to alternative surgical techniques, if necessary. Customers are asked to fill out and return the a |
| Quantity | 112 systems |
| Distribution | Worldwide Distribution --- including USA and countries of Belgium, Bulgaria, Canada, China, Denmark, France, Germany, Italy, Korea, Romania, Russia, Saudi Arabia, Singapore, Spain, Sweden, and United Kingdom. |
| FDA record | Open on fda.gov |