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
    34860
  • Event Risk Class
    II
  • Event Initiated Date
    2016-12-29
  • 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 the operator connects the unit to the mains using a non-hospital-grade mains outlet the protective earth connection may not be effective and an electrical defect inside the unit could cause a dangerous voltage to be present on the housing. the operator may not be aware of such danger when the "hospital grade mains connector required" warning label is missing which must be present in canada according to local electrical codes.

Device

MOBILEDIAGNOST WDR
  • Model / Serial
    Model Catalog: 9890 010 8952X (Lot serial: MobileDiagnost wDR Rel. 2); Model Catalog: 9890 010 8952X (Lot serial: in Canada)
  • Product Description
    MOBILEDIAGNOST WDR REL. 2
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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