Events

Recall of DRX Revolution Mobile, DRX Mobile Retrofit & DRX Transportable X-ray Systems

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Carestream Health 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-00970-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-09-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00970-1
  • 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
    Carestream health australia has received reports from overseas of unusable diagnostic images on exams where a normal exposure mode (nem) view is exposed immediately prior to an extended exposure mode (eem) view with the system in fast preview mode.
  • Action
    Carestream Health Australia is providing a firmware update that will allow NEM and EEM images to be taken in any order. The update will be provided at the next scheduled service or within 3 months. Until the firmware upgrade is installed end users are advised to only perform the EEM acquisition prior to the NEM acquisition.

Device

DRX Revolution Mobile, DRX Mobile Retrofit & DRX Transportable X-ray Systems
  • Model / Serial
    DRX Revolution Mobile, DRX Mobile Retrofit & DRX Transportable X-ray SystemsAll lot numbers affectedARTG Numbers: 194055 & 161988
  • Manufacturer
    Carestream Health Australia Pty Ltd

Manufacturer

Carestream Health Australia Pty Ltd