Recall Z-0834-2015 ยท GCJ Laparoscope, General & Plastic Surgery
Intuitive Surgical, Inc.
Fluorescence Imaging Procedure Kit, designed for use with Firefly Fluorescence Imaging for the da Vinci Si 3000 Surgical Systems. The Intuitive Surgical Endoscopic Instrument Control System (Intuitive Surgical da Vinci Surgical System Model IS3000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
| Date | Dec 19, 2014 (initiated Nov 21, 2014) |
| Status | Terminated |
| Reason | The storage conditions for indocyanine green (ICG) are not on the individual Fluorescence Imaging Procedure Kit box, the six-kit box, and the shipping box. If heat were to damage the material, the result would be a loss of fluorescence. |
| Root cause | Labeling design |
| Action | Urgent Medical Device Correction Letters were sent to customers on November 24, 2014. |
| Quantity | 1532 total both devices |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101077 | DA VINCI FLUORESCENCE IMAGING VISION SYSTEM, MODEL FF 100 Intuitive Surgical, Inc., Feb 4, 2011 |