The Recall Desk

FDA (Devices) recall action 70705

Intuitive Surgical, Inc. recalled 3 products on 2015-04-01

The FDA (Devices) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2015-04-01
Critical
0
Units
501

Why these products were recalled

Correction due to a fault that causes distal SUJ (DSUJ) failures that indicates a mismatch between the positions reported by the redundant position sensors on one of the patient cart arm joints.

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.

1–3 of 3

  • HighFDA (Devices)··2015-04-01

    Intuitive Surgical Recalls da Vinci Xi Systems Due to Sensor Fault

    Intuitive Surgical is recalling 167 da Vinci Xi Surgical Systems worldwide due to a fault causing distal SUJ failures and position sensor mismatches.

    Product
    da Vinci Xi Surgical System, IS4000; ASSY,USM,IS4000, Material number: 380647-20 and 380647-22 The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endocopic In
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2015-04-01

    Intuitive Surgical Recalls da Vinci Xi Systems Due to Sensor Fault

    Intuitive Surgical is recalling 167 da Vinci Xi Surgical Systems worldwide because a fault causes distal SUJ failures and position sensor mismatches.

    Product
    da Vinci Xi Surgical System, IS4000; ASSY,DISTAL SUJ,OUTER,IS4000, Material number: 380663-20 and 380663-21. The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgic
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2015-04-01

    Intuitive Surgical Recalls da Vinci Xi Systems Due to Joint Sensor Fault

    Intuitive Surgical is recalling 167 da Vinci Xi Surgical Systems worldwide due to a fault causing distal sensor failures and position mismatches.

    Product
    da Vinci Xi Surgical System, IS4000; Assy, Distal SUJ, Inner, IS4000 Material number: 380662-20 and 380662-21. The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surg
    Category
    Distribution
    0 states