Events

Recall of DX-M

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by AGFA HEALTHCARE 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
    23009
  • Event Risk Class
    III
  • Event Initiated Date
    2011-12-06
  • 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 dx-g or dx-m digitizer may stop during startup or during a cassette scan cycle and occasionally the images can be lost. at the time a reboot was required to get the system running again. no harm has been reported for this issue. the dx-g or dx-m digitizer may lock up during the cassette scan cycle without any further error messages. at the time reboot was required to get the system running again. no images get lost in this scenario. no harm has been reported for this issue. images did not arrive in the foreseen patient folder at the processing station. some of the lost images could be found in emergency folders and some images were lost completely. the emergency folders are not accessible to the user. in most instances there is a delay in diagnosis with potential retakes required.

Device

DX-M
  • Model / Serial
    Model Catalog: 1.0 (Lot serial: NIM_2311); Model Catalog: 5NBGQ (Lot serial: NIM_2311)
  • Product Description
    DX-M DIGITIZER SYSTEM
  • Manufacturer
    AGFA HEALTHCARE INC.

Manufacturer

AGFA HEALTHCARE INC.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Agfa-Gevaert NV
  • Source
    HC