Recall Z-2835-2018 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
The da Vinci Xi Surgical System (IS4000) Model Name: IS4000, Endoscope Controller. Model Number: 372601-16.
| Date | May 17, 2018 |
| Status | Open, Classified |
| Reason | An Endoscope Controller has been improperly calibrated during manufacturing. This improper calibration may result in the Endoscope Controller showing surgical images that are dimmer, have color imbalance or have reduced fluorescence and grayscale when using Firefly. There is also potential for increased fogging of the endoscope. |
| Root cause | Use error |
| Action | Intuitive Surgical notified customers via a "Field Safety Notice Urgent Medical Device Correction ISIFA2018-06-C da Vinci Xi Miscalibrated Endoscope Controller" letter. The letter provided: Reason for Field Action, Risk to Health, Affected Products (description, part number, serial number), Action taken by Intuitive Surgical, Actions to be taken by the Customer/ User, contact information for Further Information & Support, and an Acknowledgement Form. |
| Quantity | 1 |
| Distribution | U.S. |
| 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 |