Events

Recall of GE Centricity PACS RA1000 Workstation

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by GE Medical Systems Information Technologies.

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
    15225
  • Event Initiated Date
    2013-08-20
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: GE Healthcare Limited, 8 Tangihua Street, Auckland 1010
  • Reason
    The manufacturer has become aware of several potential safety issues due to out of context and measurement issues associated with specific workflows with this device:, 1/ in centricity ris-ic, and a ris-driven integration, the "close" button closes the exam in ris-ic, but does not close the exam in centricity pacs ra1000 workstation,, 2/ interrupted workflow could break the synchronization between nuance powerscribe 360 and centricity pacs ra1000 workstation,, 3/ interrupted workflow could break the synchronization between agfa talk and centricity pacs ra1000 workstation,, 4/ centricity pacs ra1000 workstation distance measurements may not be calculated accurately when a modality sends a study to pacs which only contains values in the imager pixel spacing (0018, 1164), and magnification factor (0018, 1114) dicom tags but does not include a value in the pixel spacing (0020,0030) dicom tag.
  • Action
    Software to be upgraded

Device

GE Centricity PACS RA1000 Workstation

Manufacturer

GE Medical Systems Information Technologies