Events

Recall of ISITE PACS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by PHILIPS ELECTRONICS LTD..

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
    101049
  • Event Risk Class
    II
  • Event Initiated Date
    2011-02-24
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    When performing measurements on a volume value image (mip mpr 3d) clinicians are able to take snapshots of their measurements in a capture window. if they do not save the capture window and they make measurement changes in the original image it updates the measurement values in the capture window but it does not update the associated graphics in the capture window. thus the measurement value no longer corresponds to the graphic displayed in the capture window. this could lead to an incorrect interpretation of the measurements which could cause an incorrect diagnosis and incorrect treatment plan.

Device

ISITE PACS
  • Model / Serial
    Model Catalog: VERSION 3.X (Lot serial: )
  • Product Description
    ISITE PACS
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

PHILIPS ELECTRONICS LTD.
  • Manufacturer Address
    MARKHAM
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    HC