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
    143498
  • Event Risk Class
    II
  • Event Initiated Date
    2015-04-17
  • 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 that when hl7 lab messages are sent to a piic ix system that has been localized forcomma delimiters the lab result is incorrectly displayed on the bedside monitor. an expected delimiter isstripped from the lab value and the number shown is of a higher magnitude than expected. if lab results areincorrect a clinician may initiate incorrect treatment or delay necessary treatment this problem only happenswhen the piic ix is configured during set up for regional settings where the delimiter is a comma. the laboption must be in use and the workflow utilizes the automatic lab interface displayed at the bedside monitor.

Device

INTELLIVUE - INFORMATION CENTER IX - SOFTWARE
  • Model / Serial
    Model Catalog: M3290B (Lot serial: 7Z4V-37N1-L); Model Catalog: M3290B (Lot serial: 1M4H-34MB-4); Model Catalog: M3290B (Lot serial: 5G4L-1CJJ-0); Model Catalog: M3290B (Lot serial: 577U-56K0-9); Model Catalog: M3290B (Lot serial: 7U00-2CJW-V); Model Catalog: M3290B (Lot serial: 4744-35J4-F)
  • 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