PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: September 23, 2015 Initiated: September 9, 2015 #Z-2782-2015

Product Description

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.

Reason for Recall

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.

Details

Recalling Firm
Intuitive Surgical, Inc.
Units Affected
1200 kits
Distribution
US Nationwide Distribution
Location
Sunnyvale, CA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Intuitive Surgical, Inc.. Units affected: 1200 kits.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on September 23, 2015. Severity: Moderate. Recall number: Z-2782-2015.