FDA-Device2015-09-23Class II
Fluorescence Imaging Procedure Kits used with the da Vinci Si and Xi Surgical Systems; Model numbers: 950156-01, 950156-02, 950156-03. Product Usage: General and plastic surgery: The da Vinci Firefly Imaging system is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging.
Intuitive Surgical, Inc.
Hazard
B. Braun 2 gang 4-way stopcocks in the Fluorescence Imaging Procedure Kit may experience damage to the sterile packaging during shipping. The damage can result in tears to the packaging and has the potential to cause a breach in sterility of the supplied stopcocks.
Sold states
US Nationwide Distribution
Affected count
1200 kits
Manufactured in
1266 Kifer Rd Bldg 100, Sunnyvale, CA, United States
Products
Fluorescence Imaging Procedure Kits used with the da Vinci Si and Xi Surgical Systems; Model numbers: 950156-01, 950156-02, 950156-03. Product Usage: General and plastic surgery: The da Vinci Firefly Imaging system is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2782-2015Don't want to check this manually?
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