Events

Recall of DX-D 100 MOBILE X-RAY UNITS

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
    93353
  • Event Risk Class
    II
  • Event Initiated Date
    2015-06-05
  • 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
    When using the dx-d 100 unit sporadic unintended movements caused by an electrostatic discharge of the unit to the ground may occur. capacitive touch screens rely on the electrical properties of the human body to enable you to operate the device with very light touches of a finger. however when liquid comes in contact with the touch screen it may incorrectly recognize this as user input.

Device

DX-D 100 MOBILE X-RAY UNITS
  • Model / Serial
    Model Catalog: SM-50HF-B-D-V (Lot serial: > 10 numbers contact mfg.); Model Catalog: SM-50HF-B-D-T (Lot serial: > 10 numbers contact mfg.); Model Catalog: SM-40HF-B-D-T (Lot serial: > 10 numbers contact mfg.); Model Catalog: SM-40HF-B-D-V (Lot serial: > 10 numbers contact mfg.); Model Catalog: SM-40HF-B-D-C (Lot serial: > 10 numbers contact mfg.); Model Catalog: SM-50HF-B-D-C (Lot serial: > 10 numbers contact mfg.)
  • Product Description
    DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D 100 TYPE 5410 OR DX-D 100 WIRELESS TYPE 5411
  • Manufacturer
    AGFA HEALTHCARE INC.

Manufacturer

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