Events

Recall of MX8000 IDT MULTISLICE C+ IMAGING SYSTEM

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
    41362
  • Event Risk Class
    III
  • Event Initiated Date
    2013-03-15
  • 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 healthcare has received a report from the field stating that when they viewed the ctdi(vol) information from the pacs system the calculations were too high. upon investigation after the image dataset was sent to the pacs system the ctdi(vol) for type 3 dicom tag 0018:9345 calculation was corrupted. instead of storing the ctdi(vol) value for each slice in the dicom tag the system took the sum of all ctdi(vol) values from all the images in the dataset and stored this value in the dicom tag.

Device

MX8000 IDT MULTISLICE C+ IMAGING SYSTEM
  • Model / Serial
    Model Catalog: OFF-EI-590 (Lot serial: 3056); Model Catalog: OFF-EI-590 (Lot serial: 3279); Model Catalog: OFF-EI-590 (Lot serial: 2530); Model Catalog: OFF-EI-590 (Lot serial: 3262); Model Catalog: OFF-EI-590 (Lot serial: 3236); Model Catalog: 4535 670 73181 (Lot serial: 2591); Model Catalog: 4535 670 73191 (Lot serial: 2557); Model Catalog: 4535 670 73181 (Lot serial: 3343); Model Catalog: 4535 670 73191 (Lot serial: 3343); Model Catalog: 4535 670 73181 (Lot serial: 9746); Model Catalog: 4535 670 73191 (Lot serial: 2596); Model Catalog: 4535 670 73181 (Lot serial: 2596); Model Catalog: 4535 670 73191 (Lot serial: 2591); Model Catalog: 4535 670 73181 (Lot serial: 2557); Model Catalog: 4535 670 73191 (Lot serial: 2589); Model Catalog: 4535 670 73181 (Lot serial: 2589); Model Catalog: 4535 670 73191 (Lot serial: 9746)
  • Product Description
    MX8000 IDT MULTISLICE C+ IMAGING SYSTEM
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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