FDAFDA · Food and drugs·Recall number Z-0835-2015
Fluorescence Imaging Procedure Kit, designed for use with Firefly Fluorescence Imaging for the da Vinci Xi 4000 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.
Published December 31, 2014 · Recall initiated: November 21, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Intuitive Surgical, Inc.
- Distributor
- Nationwide Distribution.
- Lot
- PN 950156-02
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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