Events

Recall of Fujifilm Synapse PACS software version 4.0, 4.1, 4.2, 4.3 (a picture archiving and communication 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-2016-RN-01329-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-11-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01329-1
  • 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 issue has been identified with the image processing software module when two or more patient fcr images (fuji computed radiology images stored in a proprietry format) from synapse pacs are sent simultaneously to another manufacturer's pacs . when fcr images (comprised of pixel data and the dicom header) are sent via cmove or forwarded by ebf (event based forwarding) on multiple associations simultaneously, in rare situations, one or more of the following issues can happen: a) patient a’s pixel data is changed to patient b’s pixel data and forwarded to the destination. b) the output image is corrupted and may appear as random noise. c) dicomserver crashes. if issue a) or b) happens, only the image in the destination archive is affected. images in the source synapse system are not affected. the potential risk is that pixel data for a patient’s image may not be correct in the destination (non-fujifilm) pacs. however, the radiology reports will be correct.
  • Action
    Fujifilm has applied a corrective software patch to affected PACS as a permanent fix. This action has been closed-out on 20/11/2017.

Device

Fujifilm Synapse PACS software version 4.0, 4.1, 4.2, 4.3 (a picture archiving and communication ...
  • Model / Serial
    Fujifilm Synapse PACS software version 4.0, 4.1, 4.2, 4.3 (a picture archiving and communication system)ARTG Number: 203605
  • Manufacturer
    Fujifilm Australia Pty Ltd

Manufacturer

Fujifilm Australia Pty Ltd