Events

Recall of Centricity PACS-IW with Universal Viewer Versions 5.0 SP2 and higher and Centricity Universal Viewer versions 6.0 and higher (used for storage and retrieval of images used in radiology)

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-2015-RN-01006-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-10-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01006-1
  • 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
    The products, when deployed with centricity pacs and centricity enterprise archive, or retrieving images from vendor neutral dicom archives, display inaccurate measurements on magnification views acquired from certain digital x-ray systems because certain scanner-originated magnification factors are not taken into account by universal viewer. specifically, distance measurements may not be calculated accurately when viewing projection radiography and fluoroscopy images that contain values in the imager pixel spacing (0018, 1164) and magnification factor (0018, 1114) dicom tags but does not contain a value in the pixel spacing (0028, 0030) tag. true size printing on film/paper for images produced by such modalities is also impacted. if known size fiducials are not present on the image and manual calibration is not possible, this can lead to an overestimation of distance measurements on the images. there have been no injuries reported as a result of this issue.
  • Action
    For all projection X-rays, GE Healthcare recommends that the user perform the necessary measurements on the standard contact images, and not rely on measurements made on the magnified views unless the measurements have been independently verified for each X-Ray machine installed or manually calibrated using a radio-opaque fiducial of a known size. Attention should be given to prior cases acquired previously as they may be affected by the safety issue. GE Healthcare will correct all affected products.

Device

Centricity PACS-IW with Universal Viewer Versions 5.0 SP2 and higher and Centricity Universal Vie...
  • Model / Serial
    Centricity PACS-IW with Universal Viewer Versions 5.0 SP2 and higher and Centricity Universal Viewer versions 6.0 and higher (used for storage and retrieval of images used in radiology)ARTG Number: 161079
  • Product Classification
    Radiology Devices
  • Manufacturer
    GE Healthcare IITS Australia Pty Ltd

Manufacturer

GE Healthcare IITS Australia Pty Ltd
  • Source
    DHTGA