Events

Recall of KODAK DIRECTVIEW DR 7500 SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CARESTREAM HEALTH CANADA COMPANY.

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
    22879
  • Event Risk Class
    II
  • Event Initiated Date
    2014-02-14
  • 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
    Carestream has identified that if the system user interrupts the daily switch off-set refresh detector calibration by switching the active detector from one bucky to another (e.G. table to the wall) and cancels detector calibration within 30 seconds of initiating this process the previous patient image will be displayed on the console with the current patient's name. the likelihood of this issue occurring is improbable and there have not been any reported injuries or misdiagnosis as a result.

Device

KODAK DIRECTVIEW DR 7500 SYSTEM
  • Model / Serial
    Model Catalog: 879 1345 (Lot serial: 75000216); Model Catalog: 879 1345 (Lot serial: 75000673); Model Catalog: 879 1345 (Lot serial: 75000590); Model Catalog: 879 1345 (Lot serial: 75000233); Model Catalog: 879 1345 (Lot serial: 75000150); Model Catalog: 879 1345 (Lot serial: 75000648)
  • Product Description
    KODAK DIRECTVIEW DR 7500 DUAL DETECTOR SYSTEM (USING V5 SOFTWARE)
  • Manufacturer
    CARESTREAM HEALTH CANADA COMPANY

Manufacturer

CARESTREAM HEALTH CANADA COMPANY
  • Manufacturer Address
    VAUGHAN
  • Manufacturer Parent Company (2017)
    ONEX Corp
  • Source
    HC