Events

Recall of Intuitive da Vinci Standard, S, Si and Si-e Surgical Systems

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Intuitive Surgical Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    17834
  • Event Initiated Date
    2015-01-06
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Extra notes in the data
    Recalling Organisation: Device Technologies New Zealand, 47 Arrenway Drive, Albany, AUCKLAND 0632
  • Reason
    The manufacturer is updating the user manuals, instructions for use (ifu), quick reference guides (qrg), the natural rubber latex qrg, and the instrument release kit. these changes are being made in response to 66 unique adverse event reports associated with use scenarios that were not previously addressed in these documents.
  • Action
    Instructions for use to be updated

Device

Intuitive da Vinci Standard, S, Si and Si-e Surgical Systems

Manufacturer

Intuitive Surgical Inc