The Recall Desk

FDA (Devices) recall action 69845

Intuitive Surgical, Inc. recalled 2 products on 2014-12-31

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2014-12-31
Critical
0
Units
3,064

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • ModerateFDA (Devices)··2014-12-31

    Intuitive Surgical Recalls Fluorescence Imaging Procedure Kits for Missing Storage Info

    Intuitive Surgical is recalling Fluorescence Imaging Procedure Kits because storage conditions for indocyanine green are missing from the packaging.

    Product
    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 a
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2014-12-31

    Intuitive Surgical Recalls Fluorescence Imaging Procedure Kits for Missing Storage Info

    Intuitive Surgical is recalling Fluorescence Imaging Procedure Kits because storage conditions for indocyanine green are missing from the packaging.

    Product
    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 a
    Category
    Distribution
    0 states