Events

Recall of IntelePACS(Image management system)

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-2015-RN-00404-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-05-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00404-1
  • 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
    Images successfully transmitted to intelepacs may not be available for reading in all studies, and the reader could be unaware of missing images.. this failure can be detected if the client has image count verification protocols. in addition if a large number of consecutive images are missing it will cause a noticeable gap in the anatomy.This issue can arises in two scenarios:1. for the three clients that employ ingest servers to provide temporary store-and-forward capabilities in their architecture, in some conditions, these servers fail to forward all received images to the permanent storage servers and no record of these images persist in the main archive. 2. for the remaining client architectures that do not employ temporary ingest servers, there is still a very low probability of failure for the device to properly replicate and register images when transferring them to another server.
  • Action
    For the three clients using a configuration with ingest servers as temporary storage, an immediate update process was undertaken via the Client Specific Release process (completed as of 2015-04-23) to avoid the possibility of data loss. For the remaining clients, the normal Full Release Update (FRU) will be expedited. This action has been closed-out on 5/08/2016.

Device

IntelePACS(Image management system)

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia