Events

Recall of GC80 Diagnostic X-Ray system

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-2017-RN-00653-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-06-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00653-1
  • 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
    An incident had been reported in germany to samsung electronics on 15 dec 2016 where an image was obtained with over exposure during a thorax examination using the aec function. the exposure condition was: 125kv, 180mas.As a result of the malfunction of the aec, irradiation may not terminate properly which can cause exposure until the aec back up time which is set at 500msec by default. this can cause overexposure for users.
  • Action
    Samsung will be implementing a software update on affected units in early July 2017. In the interim, users are advised that they may continue to use the GC80 system, taking precaution of any possible network disconnection between the THU and WS. Users are requested to check 1) the THU connection status when using the system and 2) the THU connection before logging in after system booting. (Please refer to recall notification for images and further details).

Device

GC80 Diagnostic X-Ray system

Manufacturer

Samsung Electronics Australia Pty Ltd