Events

Recall of PHILIPS INTELLISPACE 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
    15418
  • Event Risk Class
    II
  • Event Initiated Date
    2014-07-30
  • 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
    In intellispace pacs 4.4 system there is feature which allows the optional configuration of auto export of resolved study exception immediately after resolution. philips has become aware that when this configuration is used it is possible for a system timing issue to occur when exporting data to 3rd party devices. if this system timing issue occurs when demographics are updated such as during exception resolution and the study is immediately exported the patient demographic information can be incorrect in the exported data.

Device

PHILIPS INTELLISPACE PACS
  • Model / Serial
    Model Catalog: INTELLISPACE PACS 4.4 (Lot serial: N/A)
  • Product Description
    PHILIPS HEALTHCARE INFORMATICS INC
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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