Events

Recall of FerriScan (software for determining liver iron concentration from MRI images)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Resonance Health Analysis Services 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-01233-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2016-09-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01233-1
  • 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 has been identified that there is a misprint in the liver iron concentration (lic) measurement units on a subset of ferriscan reports. the report should include the average liver iron concentration result in mg/g dry tissue on the first line of the report and in mmol/kg dry tissue on the second line. this misprint only affects the second line result, where mg/g dry tissue is displayed rather than the correct units of mmol/kg dry tissue. the correct value (number) is displayed. the first line has both the correct value (number) and correct measurement units. an investigation by resonance health determined that the misprint only occurred in specified reports where the lic value was greater than 43 mg/g of dry tissue. as such, the misprint for the second line result only occurs in cases of extreme liver iron overload. no other reports are affected.
  • Action
    Resonance Health is advising those with affected reports of the error in the measurement units and will re-issue reports on the request of users. This action has been closed-out on 10/05/2017.

Device

FerriScan (software for determining liver iron concentration from MRI images)
  • Model / Serial
    FerriScan (software for determining liver iron concentration from MRI images)Reports with LIC > 43 mg/g of dry tissue and issued between 5 Oct 2105 to 26 Aug 2016ARTG Number: 116071
  • Manufacturer
    Resonance Health Analysis Services Pty Ltd

Manufacturer

Resonance Health Analysis Services Pty Ltd