Events

Recall of Centricity PACS RA1000 Workstation versions 3.2 and higher (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 IITS 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-2014-RN-00442-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-04-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00442-1
  • 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
    It has been identified that in a reject image workflow where multiple studies are simultaneously opened on the centricity pacs ra1000 workstation and images are rejected from the active displayed study, images from the previously displayed study may also be rejected. this issue can occur with a previously displayed study that remains open in the background.There is a delrejimg task in centricity pacs versions 3.2 and higher, that if enabled and running, in conjunction with the inadvertently rejected image issue, poses a potential patient safety hazard due to data loss. if the delrejimg task runs, the inadvertently rejected images will be permanently deleted from pacs. if you do not have the delrejimg task running, there is no potential hazard since the inadvertently rejected images remain on the system. the deletion of the inadvertently rejected images could result in missed intervention or mis-diagnosis. no patient injuries have been reported.
  • Action
    A future release of Centricity PACS will address the unintentional rejected image issue. Until the permanent fix for this issue is deployed, GE recommends customers implement workarounds identified in the customer letter. Also, a GE Healthcare service representative will remove the DelRejImg task from the task table in the Centricity PACS database. This will remove the rejected image deletion feature, and eliminate the hazard situation. Thia action has been closed-out on 28/01/2016.

Device

Centricity PACS RA1000 Workstation versions 3.2 and higher (Picture archiving and communication s...
  • Model / Serial
    Centricity PACS RA1000 Workstation versions 3.2 and higher (Picture archiving and communication system)Software versions: 3.2, 3.2.0.1, 3.2.0.2, 3.2.1, 3.2.2, 3.2.2.1, 3.2.2.2, 3.2.2.3, 3.2.6, 3.2 SP7, 3.2 SP8, 4.0, 4.0.1 & 4.0 SP3ARTG number: 162031
  • Manufacturer
    GE Healthcare IITS Australia Pty Ltd

Manufacturer

GE Healthcare IITS Australia Pty Ltd
  • Source
    DHTGA