Events

Recall of FUJIFILM FDR-1000AWS / FDR-2000AWS / FDR-3000AWS V5.1.0001-0007 with Biopsy unit (a component of FUJIFILM Digital Mammography System)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Fujifilm 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-2014-RN-00479-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-04-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00479-1
  • 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
    It was found that for software v5.1.0001-0007 used in workstation (aws), which is a component of fujifilm digital mammography system, when image enhancement processing is performed on the exposed image with an option function during biopsy, the screen may not return to the original image. depending on the enhancement parameter, the calcification may seem unclear compared to the original image. therefore, there is a potential that the tip of needle cannot reach the desired biopsy area. furthermore, after collecting the target sample, it may be difficult to ascertain whether the necessary calcification part has been properly extracted. due to these reasons, the occurrence of this issue may precipitate that a re-examination might be necessary. this image processing is an option for biopsy and does not affect other normal exposures.
  • Action
    Customers are advised to not perform image enhancement during Biopsy. In the case that a calcification becomes unclear due to enhancement processing, select the weakest enhancement processing or redisplay the image on the 1st monitor by right-clicking. FUJIFILM service personnel will contact the affected facility to arrange for a software update as a corrective measure.

Device

FUJIFILM FDR-1000AWS / FDR-2000AWS / FDR-3000AWS V5.1.0001-0007 with Biopsy unit (a component of ...
  • Model / Serial
    FUJIFILM FDR-1000AWS / FDR-2000AWS / FDR-3000AWS V5.1.0001-0007 with Biopsy unit (a component of FUJIFILM Digital Mammography System)Serial Number: 37020038ARTG Number: 159785
  • Manufacturer
    Fujifilm Australia Pty Ltd

Manufacturer

Fujifilm Australia Pty Ltd