Events

Recall of Merge CADstream, All versions (used for breast cancer or general MRI studies)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Emergo Asia Pacific Pty Ltd T/a Emergo Australia.

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-00866-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-07-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00866-1
  • 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
    Within the sureloc application, under sureloc preferences, there are two grid options: a generic grid or the ge 8-channel curved grid. a generic grid is a flat grid of 2 centimeter holes. there is no limitation on the number of blocks. selecting the incorrect grid or using an unsupported grid could result in an incorrect biopsy or missed target. there is a chance that a repeat biopsy may be required.
  • Action
    Emergo is advising users to ensure a verification scan is completed as per the User Guide to confirm correct placement prior to undertaking a biopsy. Users are also advised that if they are using a grid outside the two defined options, please contact Merge support. This action has been closed-out on 27/02/2017.

Device

Merge CADstream, All versions (used for breast cancer or general MRI studies)

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia