Events

Recall of Synapse Cardiovascular (CV) Client application, version 4.0.8 (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-2014-RN-00482-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-05-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00482-1
  • 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
    The “switch user” feature is an option in windows 7 that allows another user to open a new session with his user account without requiring the previous user to log out of the existing session. it has been discovered that running the same synapse cv client application under more than one windows user account simultaneously may cause outbound hl7 reports with incorrect data to be sent to emr. there is the potential that patients’ medical records may be altered as a result of utilizing this windows 7 function through the unintentional modification of the outbound hl7 files. this issue does not occur if individual users logout of windows 7.
  • Action
    Fujifilm does not support the use of the “Switch User” function in Windows 7 with Synapse CV. The function should be disabled on Windows 7 workstations that operate the Synapse CV application. There are several options to allow multiple users on a workstation and, if required, Fujifilm Customer Support will assist users with determining which option is best suited for each facility.

Device

Synapse Cardiovascular (CV) Client application, version 4.0.8 (Picture archiving and communicatio...
  • Model / Serial
    Synapse Cardiovascular (CV) Client application, version 4.0.8 (Picture archiving and communication system)ARTG number: 164422
  • Manufacturer
    Fujifilm Australia Pty Ltd

Manufacturer

Fujifilm Australia Pty Ltd