Events

Recall of DuraDiagnost Release 1.0, 2.0, 3.0 X-Ray systems

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Philips Electronics Australia 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-2017-RN-00726-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-06-01
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00726-1
  • 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
    Philips has discovered via a report from the field that some welding joints on the vertical carriage brackets of the tube stand may crack. as a result, the tube arm assembly may exhibit uncharacteristic sideways movement, with the tube becoming off center. if all of the welding joints cracked, the tube arm assembly could fall down and a patient on the examination table or anyone in the vicinity could be struck by the falling tube arm assembly resulting in serious injury or death.
  • Action
    A Philips Engineer will go on-site and inspect the welding joints of the tube stand vertical carriage brackets and install the safety hooks structure, which will prevent the tube arm assembly from falling down even if all the bracket welding joints are cracked. In the interim, users are to stop using the device.

Device

DuraDiagnost Release 1.0, 2.0, 3.0 X-Ray systems
  • Model / Serial
    DuraDiagnost Release 1.0, 2.0, 3.0 X-Ray systemsDuraDiagnost R1.0 Product Number: 712210DuraDiagnost R2.0 and R3.0Product Number: 712211ARTG Number: 207424
  • Product Classification
    Radiology Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    DHTGA