Events

Recall of INTELLIVUE - INFORMATION CENTER IX - SOFTWARE

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
    59926
  • Event Risk Class
    II
  • Event Initiated Date
    2018-01-08
  • 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
    Philips has become aware of an issue affects all piic ix surveillance and patient link revisions. the issue will occur after a surveillance station is first restarted during the year 2018. after that initial restart the station will thereafter no longer perform patient discharge and transfer operations. subsequent application restarts will occur when any of the following operations are performed: -discharging a patient under certain conditions -transferring a patient (from bedside or central station) -resolving patient conflicts (from bedside or central station) where bedside's patient must overwrite piic ix's patient (revision b.0x and c.0x only) -clearing a surveillance sector -assigning a bed to an empty surveillance sector the surveillance station will continue to monitor patients after any restart. (for french translation please see e-file).

Device

INTELLIVUE - INFORMATION CENTER IX - SOFTWARE
  • Model / Serial
    Model Catalog: M3290B (Lot serial: N/A)
  • Product Description
    INTELLIVUE - INFORMATION CENTRE IX - SOFTWARE
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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