Events

Recall of MUX-100H SYSTEM

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

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
    31672
  • Event Risk Class
    II
  • Event Initiated Date
    2005-01-06
  • 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 units may contain spacer assemblies that do not comply with sid standards. the spacers may fail at the time of compliance testing. shimadzu is conducting field testing of all units.

Device

MUX-100H SYSTEM
  • Model / Serial
    Model Catalog: MUX-100H (Lot serial: All)
  • Product Description
    Mobile Radiography System
  • Manufacturer
    SHIMADZU CORPORATION

Manufacturer

SHIMADZU CORPORATION
  • Manufacturer Address
    NAKAGYO-KU
  • Source
    HC