Recall of QDR 4500 BONE DENSITOMETER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CHRISTIE INNOMED 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
    24502
  • Event Risk Class
    II
  • Event Initiated Date
    2008-10-07
  • Event Country
  • 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
    The software defect on hologic bone densitometers could cause a change in the analysis results obtained from the reanalysis of a qdr scan analysed with the previous version of the qdr operating system.

Device

  • Model / Serial
    Model Catalog: QDR 4500-C ELITE (Lot serial: ); Model Catalog: QDR 4500-W ELITE (Lot serial: ); Model Catalog: QDR 4500-W (Lot serial: ); Model Catalog: QDR 4500-C (Lot serial: ); Model Catalog: DISCOVERY-W (Lot serial: ); Model Catalog: EXPLORER (Lot serial: ); Model Catalog: DISCOVERY-A (Lot serial: ); Model Catalog: DISCOVERY-C (Lot serial: ); Model Catalog: DELPHI-A (Lot serial: Apex Software v.2.0); Model Catalog: DELPHI-W (Lot serial: Apex Software v.2.0); Model Catalog: DELPHI-C (Lot serial: Apex Software v.2.0); Model Catalog: DELPHI-C (Lot serial: Apex Software v.2.1); Model Catalog: DELPHI-W (Lot serial: Apex Software v.2.1); Model Catalog: DELPHI-C (Lot serial: Apex Software v.2.2); Model Catalog: DELPHI-W (Lot serial: Apex Software v.2.2); Model Catalog: DELPHI-A (Lot serial: Apex Software v.2.2); Model Catalog: DELPHI-A (Lot serial: Apex Software v.2.1)
  • Product Description
    Apex 2.0 2.1 2.2 software
  • Manufacturer

Manufacturer