Events

Recall of DIGITAL DIAGNOST

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
    94848
  • Event Risk Class
    III
  • Event Initiated Date
    2015-07-30
  • 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
    There is the possibility that during stitching on the table a failure occurs and the last single image is not available. in this case a retake is necessary. there is the possibility that line artefacts will be visible at the edge of the x-ray image when using the skyplate detector.

Device

DIGITAL DIAGNOST
  • Model / Serial
    Model Catalog: 9890 010 83904 (Lot serial: SN15000052); Model Catalog: 9890 010 83904 (Lot serial: SN15000126); Model Catalog: 9890 010 83904 (Lot serial: SN15000092); Model Catalog: 9890 010 83904 (Lot serial: SN15000127)
  • Product Description
    DIGITALDIAGNOST SW 4.1.1 SP1
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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