Recall Z-1870-2014 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
IS4000 da Vinci Xi - Endoscope accessory; 30 Degree, 8mm Endoscope. Intuitive Surgical Inc.
| Date | Jun 25, 2014 (initiated Jun 11, 2014) |
| Status | Terminated |
| Reason | In some procedures when using the endoscope in conjunction with the IS4000 (da Vinci Xi) System, the surgical view has an orange-yellow tint which can make it hard to differentiate between tissue |
| Root cause | Device Design |
| Action | Medical Device Recall notifications were sent to the 4 affected sites on June 11, 2014. Letters describe the problem and the potential health risk. The two model numbers of the endoscope are listed and the statement that ISI will perform a software upgrade to the da Vinci System and replace the endoscopes. Letters request that the following actions take place: - Ensure that all appropriate personnel are fully informed of the information provided in the notification letter. - Complete and return the acknowledgement form using instructions provided. - Retain a copy of The letter for your recor |
| Quantity | 20 units |
| Distribution | Distributed in the states of FL, TX, and NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131861 | DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIES Intuitive Surgical, Inc., Mar 28, 2014 |