Events

Recall of Drystar DT 2 C Hardcopy Film 14" x 17"

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by AGFA HealthCare Australia.

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-01371-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-10-30
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01371-1
  • 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
    Agfa healthcare is advising that due to an error in manufacturing, specific film boxes have unreadable rf-tags. if these boxes are used in printers, the printer will generate an error message, and it will not be possible to print images. if users were able to use the affected film there is no problem with the image quality or the diagnostic properties.
  • Action
    Agfa Healthcare is advising users to use an alternative film if the issue occurs.

Device

Drystar DT 2 C Hardcopy Film 14" x 17"
  • Model / Serial
    Drystar DT 2 C Hardcopy Film 14" x 17"Reference: EKMCUBatch Numbers: 36650011 (exp 2018-06) and 69030031 (exp 2018-10)ARTG Number: 119352 (AGFA HealthCare Australia - Photographic film, diagnostic imaging)
  • Manufacturer
    AGFA HealthCare Australia

Manufacturer

AGFA HealthCare Australia