Events

Recall of Samsung DR GC80

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Samsung Medison Co 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
    21588
  • Event Initiated Date
    2017-06-28
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Samsung Electronics New Zealand, 24 The Warehouse Way, Northcote, Auckland 0627
  • Reason
    An incident had been reported on 15 dec 2016 that an image was obtained with over exposure during a thorax examination using the aec function. the exposure condition was: 125kv, 180mas.
  • Action
    Instructions for use to be updated

Device

Samsung DR GC80

Manufacturer

Samsung Medison Co Ltd