Events

Recall of Optima CT660, Brivo CT385, Discovery PET/CT 610 and Discovery PET/CT 710 Systems (when used with certain PACS systems)

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-00326-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-04-16
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00326-1
  • 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
    There is an issue related with the direct multi-planar reformat (dmpr) function and screen saved images on the scanner. the dmpr and screen save functionality may possibly generate the same series uid. it has been seen that some picture archiving and communication system (pacs) may combine series under a patient using only the series uid, although all images are correctly annotated. this issue can cause additional images from a different patient and images from two or more patients to appear in one exam. please note that this issue has only been seen on pacs systems manufactured by intelerad (intelepacs 4-3-1-p350 and intelebrowser -4-3-1-p350) at this time.
  • Action
    GE Healthcare is recommending that customers discontinue using the DMPR functionality, if they are using the above PACS version or if they see similar issues from their current PACS and utilise an alternative capability, such as Batch-mode Reformat on the GE AW, AW server or scanner operator console or 3D reformat save on their 3D PACS viewer. GE Healthcare is planning to implement the permanent correction to affected systems when it is available.

Device

Optima CT660, Brivo CT385, Discovery PET/CT 610 and Discovery PET/CT 710 Systems (when used with ...
  • Model / Serial
    Optima CT660, Brivo CT385, Discovery PET/CT 610 and Discovery PET/CT 710 Systems (when used with certain PACS systems)ARTG Number: 156650
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd