Events

Recall of Carestream PACS Client Workstation version 11.3.2.0 / 11.3.2.4 / 11.4

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Carestream Health 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-2013-RN-01022-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-10-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01022-1
  • 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
    Carestream health australia has received one report from overseas where under very specific conditions, some images from multi-slice studies such as ct and mr may not load into the viewer application. an incorrect number of images loaded may potentially lead to an incomplete study report from those images in v11.3.2.X and v11.4 installations in circumstances where usage of multi-slice data is part of the workflow scenarios.This problem occurs infrequently and only when all of the following conditions are met:1) the version installed is v11.3.2 or v11.3.2.4 or v11.42) the exam type is from multi-slice modalities3) the images are requested to load into a pre-defined hanging protocol where at least one of the hanging protocol groups includes more than 100 images.4) a timing conflict occurs between 2 processes responsible for the load of images into memory.
  • Action
    Users are advised that the software patch will be installed by Carestream Health Australia's engineers to address the problem. Users are also informed that should a user notice the problem prior to deployment of a permanent fix, it can easily be resolved by reapplying the same display protocol.

Device

Carestream PACS Client Workstation version 11.3.2.0 / 11.3.2.4 / 11.4
  • Model / Serial
    Carestream PACS Client Workstation version 11.3.2.0 / 11.3.2.4 / 11.4Catalogue number & description:1308519 VIRT PWR Reading Basic SW Workgroup1530633 VIRT PWR Reading Basic SW 8 Pack1467067 Virtual Reading Basic SW Workgroup1405794 Virtual Reading Basic SW 8 Pack8171837 Virtual Enterprise SW StandaloneARTG Number: 135310
  • Manufacturer
    Carestream Health Australia Pty Ltd

Manufacturer

Carestream Health Australia Pty Ltd