Events

Recall of KODAK DIRECTVIEW DR 9000 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
    136515
  • Event Risk Class
    II
  • Event Initiated Date
    2014-05-29
  • 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
    Carestream has identified that in the case of a control system failure the dr 9000 u-arm may move downward unexpectedly when the radiology technologist is positioning the equipment using the "up" or "down" device control buttons. this downward movement occurs at three times the normal rate of speed and will continue until the device control button is released the emergency stop button is activated or the equipment bump sensor contacts an object. there is a potential for injury if this issue occurs for patients positioned under the u-arm for decubitus exams.

Device

KODAK DIRECTVIEW DR 9000 SYSTEM
  • Model / Serial
    Model Catalog: 851 9530 (Lot serial: 123); Model Catalog: 851 9530 (Lot serial: 1603U0024); Model Catalog: 851 9530 (Lot serial: 140); Model Catalog: 851 9530 (Lot serial: 102)
  • Product Description
    KODAK DIRECTVIEW DR 9000 SYSTEM
  • Manufacturer
    CARESTREAM HEALTH CANADA COMPANY

Manufacturer

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