The Recall Desk

FDA (Devices) recall action 65590

Intuitive Surgical, Inc. recalled 4 products on 2013-07-17

The FDA (Devices) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2013-07-17
Critical
0
Units
120

Why these products were recalled

Factory testing on da Vinci Si Surgical Systems may not be in compliance with UL Standards as one of the testing devices was found to be working incorrectly.

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.

States named across these recalls

1–4 of 4

  • ModerateFDA (Devices)··2013-07-17

    Intuitive Surgical Recalls da Vinci Si Surgeon Side Carts for Testing Compliance

    Intuitive Surgical is recalling 30 da Vinci Si Surgeon Side Carts because factory testing may not comply with UL standards due to a malfunctioning test device.

    Product
    da Vinci Si Surgeon Side Cart, model number SS3000; Manufactured by Intuitive Surgical, Sunnyvale, CA 94086. Intuitive Surgical endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments. It is intended fo
    Category
    Distribution
    10 states
  • ModerateFDA (Devices)··2013-07-17

    Intuitive Surgical Recalls da Vinci Si Vision System Carts

    Intuitive Surgical is recalling 30 da Vinci Si Vision System Carts because factory testing may not have complied with UL standards due to a malfunctioning test device.

    Product
    da Vinci Si Vision System Cart, model number VS3000; Manufactured by Intuitive Surgical, Sunnyvale, CA 94086. Intuitive Surgical endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments. It is intended f
    Category
    Distribution
    10 states
  • ModerateFDA (Devices)··2013-07-17

    Intuitive Surgical Recalls da Vinci Dual Camera Controllers for Testing Compliance

    Intuitive Surgical is recalling 30 da Vinci Dual Camera Controllers because factory testing may not have complied with UL standards due to a malfunctioning test device.

    Product
    da Vinci Dual Camera Controller, model number DC3000; Manufactured by Intuitive Surgical, Sunnyvale, CA 94086. Intuitive Surgical endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments. It is intended
    Category
    Distribution
    10 states
  • ModerateFDA (Devices)··2013-07-17

    Intuitive Surgical Recalls da Vinci Instrument Control Boxes

    Intuitive Surgical is recalling 30 da Vinci Instrument Control Boxes because factory testing may not have met UL standards due to a malfunctioning test device.

    Product
    da Vinci Instrument Control Box, model number ICB3000; Manufactured by Intuitive Surgical, Sunnyvale, CA 94086. Intuitive Surgical endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments. It is intended
    Category
    Distribution
    10 states