Events

Recall of DIAGNOST 97

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
    65193
  • Event Risk Class
    II
  • Event Initiated Date
    2011-04-04
  • 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
    During examination if the patient is positioned with his knees pointed to the rear of the system and the operator performs a wrong movement of the scanning beam downwards instead of upwards the leg(s) of the patient might collide with the stand and get squeezed potentially resulting in a (serious) injury.

Device

DIAGNOST 97
  • Model / Serial
    Model Catalog: MII 3061 (Lot serial: ); Model Catalog: MRC 0651 (Lot serial: ); Model Catalog: 70851 (Lot serial: ); Model Catalog: 70850 (Lot serial: )
  • Product Description
    DIAGNOST 97
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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