FDA Enforcement
Class II
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
·
Reported December 31, 2014
Enforcement
- Recall Number
- Z-0834-2015
- Event ID
- 69845
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Intuitive Surgical, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 31, 2014
- Initiation Date
- November 21, 2014
- Classification Date
- December 19, 2014
- Termination Date
- February 20, 2015
- Address
- 1266 Kifer Rd Bldg 100, Sunnyvale, CA, 94086-5304, United States
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.
Code Info
PN 950156-01
Distribution
Nationwide Distribution.
Quantity
1532 total both devices