The Recall Desk

FDA (Devices) recall action 83482

Intuitive Surgical Inc recalled 2 products on 2020-05-13

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
2020-05-13
Critical
0
Units
—

Why these products were recalled

Failure of Universal Surgical Manipulators due to a high friction points, resulting in an increase of arm movement to include: feelings of resistance, hesitation, and jerking.

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

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2020-05-13

    Intuitive Surgical Recalls da Vinci Xi Universal Surgical Manipulators

    Intuitive Surgical is recalling 270 Universal Surgical Manipulator units from da Vinci Xi systems due to high friction causing arm movement issues.

    Product
    da Vinci Xi Surgical System, IS4000 - Product Usage: The da Vinci Xi surgical system (IS4000) is made of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The Patient Cart is the operative component of the IS4000 system and its prim
    Category
    Distribution
    23 states
  • HighFDA (Devices)··2020-05-13

    Intuitive Surgical Recalls da Vinci X Universal Surgical Manipulators

    Intuitive Surgical is recalling 270 Universal Surgical Manipulators for da Vinci X systems due to high friction causing arm movement issues.

    Product
    da Vinci X Surgical System, IS4200 - Product Usage: The da Vinci Xi surgical system (IS4000) is made of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The Patient Cart is the operative component of the IS4000 system and its prima
    Category
    Distribution
    23 states