Events

Recall of Synapse Cardiovascular (CV) Software

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-2018-RN-00504-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-06-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00504-1
  • 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
    Fujiflm has become aware of a malfunction in the system where inconsistent mitral valve mean pressure gradient values are being reported. the values are only affected when measuring multiple velocity traces in patients with an irregular heart rhythm, with mitral and tricuspid valve stenosis, using the synapse cv measurement tools. multiple traces measured on the modality and transmitted to synapse cv are not affected.To date, there have been no reported patient injuries as a result of this issue. this malfunction does not impact the advances reporting system and there have been no reports of any other measurements or calculations being affected.
  • Action
    Fujifilm is advising users not to perform sequential multiple velocity trace measurements for mitral, tricuspid, aortic or pulmonic valves in the Synapse Cardiovascular analysis package. If averaging needs to be performed in Synapse Cardiovascular analysis package, users are advised to follow the steps outlined in the Customer Letter. This issue has been corrected in Synapse CV 6.1.0 and higher versions

Device

Synapse Cardiovascular (CV) Software
  • Model / Serial
    Synapse Cardiovascular (CV) SoftwareSoftware versions 4.0.2 to 6.0.4.1ARTG Number: 164422(Fujifilm Australia Pty Ltd - Picture archiving and communication system, software)
  • Manufacturer
    Fujifilm Australia Pty Ltd

Manufacturer

Fujifilm Australia Pty Ltd