Events

Recall of Centricity PACS RA1000 Workstation (Picture Archiving and Communication System)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by GE Healthcare 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-00868-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-08-26
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00868-1
  • 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
    Ge healthcare has become aware of potential safety issues due to out of context and measurement issues associated with specific workflows of centricity pacs ra1000 workstations.
  • Action
    GE Healthcare are providing a software update to correct the issue (version 4.0 SP3).The update can only be applied to versions 3.2.X and 4.01. Customers on previous versions must first upgrade to 3.2 before applying update 4.0 SP3. Once 4.0 SP3 (FMI 85285) is released, all media required to upgrade from 3.1.1.2 to 3.2 to 4.0 SP3 are included in the FMI 85285 media kit. Thia action has been closed on 28/01/2016

Device

Centricity PACS RA1000 Workstation (Picture Archiving and Communication System)
  • Model / Serial
    Centricity PACS RA1000 Workstation (Picture Archiving and Communication System)All Versions below 4.0.3ARTG Number: 120196
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd