Events

Recall of Image Suite Software Versions 3.0 and 4.0 (Radiology picture archiving and communication system)Image Suite Software Versions 3.0 (customers with Mini-PACS Options and Hot Fix 3004 software patch) and 4.0 (customers with Mini-PACS and DICOM Store)

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-2016-RN-00501-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-04-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00501-1
  • 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 has identified a software issue related to image orientation. if the image suite software receives a computed tomography (ct) or magnetic resonance (mr) image with the image orientation (patient) tag specified, and the overlay is configured to display this tag, the left (l) and right (r) and anterior (a) and posterior (p) overlay text will be displayed opposite. that is, the left side is marked r and the right marked l and the anterior marked p and the posterior marked a. this could result in delays in a misdiagnosis or improper patient care.There has not been any diagnosis errors reported.
  • Action
    Carestream Health Australia will contact the affected customers to update the software on the device to correct this issue. In the interim, until the software update has occurred, customers who use Image Suite for CT or MR images should make users aware of the problem and take additional steps to check correct orientation of any markers. A review of past patients’ results is recommended at the discretion of the clinical director/radiologist.

Device

Image Suite Software Versions 3.0 and 4.0 (Radiology picture archiving and communication system)I...
  • Model / Serial
    Image Suite Software Versions 3.0 and 4.0 (Radiology picture archiving and communication system)Image Suite Software Versions 3.0 (customers with Mini-PACS Options and Hot Fix 3004 software patch) and 4.0 (customers with Mini-PACS and DICOM Store)ARTG number: 172338
  • Manufacturer
    Carestream Health Australia Pty Ltd

Manufacturer

Carestream Health Australia Pty Ltd