Events

Recall of MDA SYSTEM - 180 INSTRUMENT - CLASS 2

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BIOMERIEUX CANADA INC..

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
    56205
  • Event Risk Class
    I
  • Event Initiated Date
    2003-11-26
  • 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
    Mandatory instrument retrofit:complaint regarding probe movements when the mda instrument has been suspended and the shield is open due to dust accumulation on the shield sensor.

Device

MDA SYSTEM - 180 INSTRUMENT - CLASS 2
  • Model / Serial
    Model Catalog: 200375 (Lot serial: 310MA0547); Model Catalog: 200375 (Lot serial: 406MA0605); Model Catalog: 200375 (Lot serial: 202MA1523); Model Catalog: 200375 (Lot serial: 802MA0883); Model Catalog: 200375 (Lot serial: 802MA0890); Model Catalog: 200375 (Lot serial: 601 MA 0788); Model Catalog: 200375 (Lot serial: 905 MAO 927); Model Catalog: 200375 (Lot serial: 702 MA 0851); Model Catalog: 200375 (Lot serial: 612 MA 0839); Model Catalog: 200375 (Lot serial: 406MA0603); Model Catalog: 200375 (Lot serial: 411MA0671); Model Catalog: 200375 (Lot serial: 407MA0611); Model Catalog: 200375 (Lot serial: 408MA0629); Model Catalog: 200375 (Lot serial: 306MA0525); Model Catalog: 200375 (Lot serial: 410MA0659); Model Catalog: 200375 (Lot serial: 611MA0833); Model Catalog: 200375 (Lot serial: 507MA0743); Model Catalog: 200375 (Lot serial: 306MA0526); Model Catalog: 200375 (Lot serial: 408MA0616); Model Catalog: 200375 (Lot serial: 501MA0693); Model Catalog: 200375 (Lot serial: 002MA0949); Model Catalog: 200375 (Lot s
  • Product Description
    MDA 180 & MDA II
  • Manufacturer
    BIOMERIEUX CANADA INC.

Manufacturer

BIOMERIEUX CANADA INC.