Events

Recall of CS 8100 & CS 8100 3D (A diagnostic dental x-ray system)

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-2015-RN-00073-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-01-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00073-1
  • 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 a report that the column of a cs 8100 demonstration device descended unexpectedly as one of the two retaining clips (circlips) that holds the locating pin in place was missing. if a circlip is not placed on both ends of the locating pin, it is possible that movement and transport of a unit can cause the pin to move out of position, or fall out completely. testing showed the device operation could appear normal for several lifting cycles after the pin fell out completely due to friction holding the ends of two units together, but the jack would eventually slip off the base plate stand. no other reports, complaints or injuries of this type (related to missing circlip) have been received since the device was introduced into commercial distribution in 2012.
  • Action
    Carestream Health Australia is organising a service call and a service engineer will attend the user’s site, make a detailed inspection and replace the column assembly if required. This action has been closed-out on 24/05/2016.

Device

CS 8100 & CS 8100 3D (A diagnostic dental x-ray system)
  • Model / Serial
    CS 8100 & CS 8100 3D (A diagnostic dental x-ray system)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.Manufacturing Date: June 2012 to September 2014ARTG Number: 136114 and 136106
  • Product Classification
    Radiology Devices
  • Manufacturer
    Carestream Health Australia Pty Ltd

Manufacturer

Carestream Health Australia Pty Ltd