Events

Recall of MOBILEDIAGNOST WDR

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

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
    45547
  • Event Risk Class
    III
  • Event Initiated Date
    2016-04-13
  • 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
    Philips has become aware of the following issues: 1. the system may sporadically apply the default x-ray exposure parameters for an adult (patient type: "normal") even though the patient type "newborn" was selected and is displayed in the generator control area of the eleva user interface. 2. under certain conditions the detector might not be ready for examination. released x-ray might lead to an image with artifacts and a retake is required. while the attachment process is running the detector might be too short in front of the ir (infrared) sensor and the problem of the washed out images can appear if an exposure is taken right after that.

Device

MOBILEDIAGNOST WDR
  • Model / Serial
    Model Catalog: 9890 010 8952X (Lot serial: ALL)
  • Product Description
    MOBILEDIAGNOST WDR
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

PHILIPS ELECTRONICS LTD.
  • Manufacturer Address
    MARKHAM
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    HC