Events

Recall of MDC PACS R2.3 SP2 HF6 and MDC PACS R2.3 SP2 HF7 (Picture, archiving and communication system)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Philips Electronics Australia 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-01110-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-10-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01110-1
  • 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
    A software error exists that changes the study time sent from modalities when it ends in zero(es) and incorrectly displays it in the pacs work list. the result is that examinations are displayed with a study time of 00:00:00 or 24:00:00 instead of the actual time the study was taken at, resulting in the chronological order of these exams being incorrectly displayed. this incorrect display of study time/ incorrect chronological order may result in patient misdiagnosis.
  • Action
    Philips is advising users to rely on the study time displayed in DiagNET viewer and not in the PACS client worklist in case studies acquired on the same date. A software update will be provided to permanently correct the issue.

Device

MDC PACS R2.3 SP2 HF6 and MDC PACS R2.3 SP2 HF7 (Picture, archiving and communication system)
  • Model / Serial
    MDC PACS R2.3 SP2 HF6 and MDC PACS R2.3 SP2 HF7 (Picture, archiving and communication system)Serial Number: MCD121100431ARTG Number: 207252
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    DHTGA