Events

Recall of Samsung Digital X-Ray System GC80

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Samsung Electronics 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-2018-RN-00671-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-06-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00671-1
  • 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
    Two issues have been identified with the samsung digital x-ray system gc80:1. if the user does not completely close the detector tray in the table or stand, the system turns into the portable mode or the multi-portable mode and auto exposure control (aec) turns off. at this time, the screen of workstation and the screen of tube head unit (thu) show the portable mode on or the multi portable mode on and aec off. if the user makes an exposure without checking, it may be irradiated differently than intended and produce an unintended image.2. if the user incorrectly attempts to use a portable detector within the table detector or stand detector areas with the auto detector option switched on, the system may automatically select the table or stand detectors if the focal spot is met. in this situation, if the user attempts an exposure of the portable detector without checking which detector is selected, it may be irradiated differently than intended and produce an unintended image.
  • Action
    Samsung is advising users: 1. Carefully close the detector tray and check that the detector tray is completely closed. 2. When using a portable detector: a. ensure the portable detector is placed outside the table detector or stand detector area when the auto detector option is switched on; or b. switch off the auto detector option before exposing patients with a portable detector placed within the table or stand detector areas. 3. Always carefully check the screen of Workstation or the screen of THU before making an exposure, and be sure to check the Receptor (4), AEC mode (7,8), and the exposure condition (1,2,3,5,6,9,10,11,12). If the intended detector is not set, please select the detector to be used. Samsung is planning to release updated software (expected to be available 30 June 2018) to prevent the outlined issues occurring. Implementation of the software update will be carried out by Quantum Healthcare Pty Ltd.

Device

Samsung Digital X-Ray System GC80
  • Model / Serial
    Samsung Digital X-Ray System GC80ARTG Number: 224370(Samsung Electronics Australia - X-ray system, diagnostic, general-purpose, stationary, digital)
  • Manufacturer
    Samsung Electronics Australia Pty Ltd

Manufacturer

Samsung Electronics Australia Pty Ltd