FDA Recall
Terminated
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.
Recall: Z-0834-2015
·
Initiated November 21, 2014
Recall
- Recall Number
- Z-0834-2015
- Event Number
- 69845
- Firm
- Intuitive Surgical, Inc.
- FEI Number
- 3001675293
- Product Code
- GCJ
- Status
- Terminated
- Root Cause
- Labeling design
- Initiated
- November 21, 2014
- Posted
- December 19, 2014
- Terminated
- February 20, 2015
- Address
- 1266 Kifer Rd, Bldg 100, Sunnyvale, CA, 94086-5304
Description
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.
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.
Action
Urgent Medical Device Correction Letters were sent to customers on November 24, 2014.
Distribution
Nationwide Distribution.
Quantity
1532 total both devices