Events

Recall of IntelePACS with software versions 4-3-1 and upAffected software versions: PACS 4-3-1 R49, PACS 4-3-2 R11, PACS 4-3-4 R39, PACS 4-6-1 R107, PACS 4-8-1 R65, PACS 4-9-1 R33, PACS 4-10-1 R61, PACS 4-11-1 R58, PACS 4-12-1 R45, PACS 4-14-1 R24, PACS 4-15-1 R7

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-2017-RN-01434-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-11-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01434-1
  • 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
    Intelerad medical systems received a complaint from a client notifying a problem that could occur on the intelepacs software. the issue is triggered when plain text reports from external sources have been modified to be html compatible, and by the presence of the less than (<) character in the report. when viewing a report, the less than character is not present while it was there in the original report received by intelepacs. in other cases, when the character is present in a combination with other characters, parts of the report text following the less than character are not displayed depending on the intelerad application used by the end-user to review the reports.There is a possibility that incomplete information is presented to the radiologist or referring physician. the absence of the information in the report could affect the decision made in relation with the patient care.
  • Action
    Emergo is advising users who utilise reports with HTML from external sources, that the affected issue may occur depending on the HTML formatting provided by the external source. If users are affected, a review of configurations of the external source is recommended. Intelerad is advising users that a configuration change and software upgrade will be implemented as a permanent correction.

Device

IntelePACS with software versions 4-3-1 and upAffected software versions: PACS 4-3-1 R49, PACS 4-...
  • Model / Serial
    IntelePACS with software versions 4-3-1 and upAffected software versions: PACS 4-3-1 R49, PACS 4-3-2 R11, PACS 4-3-4 R39, PACS 4-6-1 R107, PACS 4-8-1 R65, PACS 4-9-1 R33, PACS 4-10-1 R61, PACS 4-11-1 R58, PACS 4-12-1 R45, PACS 4-14-1 R24, PACS 4-15-1 R7ARTG Number: 149923
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia