Events

Recall of MOBILE X-RAY SYSTEM MOBILEDART EVOLUTION

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CHRISTIE INNOMED 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
    85304
  • Event Risk Class
    II
  • Event Initiated Date
    2015-11-26
  • 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
    Under specific conditions a software error occurs during the addition of annotations to radiographic images which prevent the transmission of the image to the image server.

Device

MOBILE X-RAY SYSTEM MOBILEDART EVOLUTION
  • Model / Serial
    Model Catalog: 563-79000-21 (Lot serial: N/A)
  • Product Description
    Shimadzu Mobile X-Ray System MobileDart Evolution
  • Manufacturer
    CHRISTIE INNOMED INC.

Manufacturer

CHRISTIE INNOMED INC.