Recall Z-1191-2016 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
da Vinci Si (IS3000) and da Vinci Xi (IS4000) Surgeon Side Console (SSC)Touchpad; Model number 187505-04; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization.
| Date | Feb 16, 2016 |
| Status | Terminated |
| Reason | |
| Root cause | Other |
| Action | Urgent Medical Device Recall letters were sent on March 2, 2016. Letters advised users of the issue and that Intuitive Representative will visit each site to replace the affected compact flash card. |
| Quantity | 542 (351 SCC Touchpads and 191 PSC touchpads) |
| Distribution | US and Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, India, Israel, Italy, Japan, Malaysia, Monaco, Netherlands, Philippines, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, South Korea, Sweden, Switzerland, Taiwa |
| FDA record | Open on fda.gov |