The Recall Desk

FDA (Devices) recall action 66524

Intuitive Surgical, Inc. recalled 2 products on 2013-11-06

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
2013-11-06
Critical
0
Units
—

Why these products were recalled

A limited number of FDA-cleared instruments for da Vinci Single Site use, Bipolar Maryland and curved needle Driver, were shipped without the correct revision of the user manual which provided added instruction for use of these additional Single Site instruments including indication, warnings and precautions.

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

1–2 of 2

  • ModerateFDA (Devices)··2013-11-06

    Intuitive Surgical da Vinci Single Site Instruments Recalled for Missing Manual Revisions

    Intuitive Surgical is recalling specific da Vinci Single Site instruments because they were shipped without the correct user manual revision, which contains necessary instructions, warnings, and precautions.

    Product
    Single Site Curved Needed Driver Intuitive Surgical, Sunnyvale, CA. 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2013-11-06

    Intuitive Surgical Recalls da Vinci Single Site Instruments for Missing Manual Revisions

    Intuitive Surgical is recalling da Vinci Single Site Bipolar Maryland Forceps and curved needle drivers shipped with incorrect user manuals.

    Product
    Single Site Bipolar Maryland Forceps Intuitive Surgical, Sunnyvale, CA. 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environm
    Category
    Distribution
    0 states