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
    26539
  • Event Risk Class
    III
  • Event Initiated Date
    2013-07-15
  • 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
    The ct system phantom supplied with the affected scanners has a special pin by which the customer can check the low contrast (lc) detectability for quality assurance. this pin consists of a nylon (aculon) body with six smaller lexan pins of 3 mm 4 mm 5mm 6 mm 7 mm and 8 mm diameters which have contrast difference of approximately 1% from aculon. the lc test is performed by visually inspecting the section and selecting the smallest detectable lexan pin for a predefined scan protocol as defined in the instructions for use (ifu) manual. this manufacturer-recommended procedure is subjective in nature and needs to be performed on several scans and by different people to be reliable. the pin visibility deteriorates over time because of slow water absorption. as the pin visibility deteriorates the test becomes unreliable and inaccurate.

Device

MX8000 IDT MULTISLICE C+ IMAGING SYSTEM
  • Model / Serial
    Model Catalog: OFF-EI-590 (Lot serial: ); Model Catalog: 362299 (Lot serial: ); Model Catalog: 4535 670 73191 (Lot serial: N/A FOR ALL); Model Catalog: 4535 670 73181 (Lot serial: N/A FOR ALL)
  • 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