Events

Recall of Kodak 2100 & 2200 Intraoral X-ray System (dental x-ray)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Carestream Health Australia Pty 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
    RC-2014-RN-00142-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-02-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00142-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Carestream health australia pty ltd has received advice that there were five incidents overseas where an early failure of the device occurred where pivot/bracket of the arm broke allowing the arm to drop to 90°.The failure is not immediate and would be noted by the user as part of the routine maintenance inspection, before the arm can fall. should the arm fall, there is a risk of injury by impact to the patient or user.
  • Action
    To address this issue, a service engineer will attend the customer site, make a detailed inspection and install a bracket modification/replacement kit to address the problem. In the interim, customers are recommended to undertake regular inspections of their units to ensure that the arm has not failed. This action has been closed-out on 01/02/2016.

Device

Kodak 2100 & 2200 Intraoral X-ray System (dental x-ray)
  • Model / Serial
    Kodak 2100 & 2200 Intraoral X-ray System (dental x-ray)Serial numbers starting: WEYA618-627, WF, WG, WH, WI, WJ, WK, WL, XA,XB, XC, XD, XE, XF, XG, XH, XI, XJ, XK, XL, YA, YB, YC, YD.ARTG inclusion number: 136106
  • Manufacturer
    Carestream Health Australia Pty Ltd

Manufacturer

Carestream Health Australia Pty Ltd