Events

Recall of Philips Trauma Diagnost X-ray SystemsAll Trauma Diagnost systems delivered prior to 8th of July 2007 are affected.

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-2015-RN-00735-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-08-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00735-1
  • 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
    If two of the three fixation bolts of the trauma supporting block connecting the trauma arm with the cs telescope arm are cracked out of its thread, the trauma arm is no longer fastened securely. subsequently, the 3rd bolt may easily break during normal use and the trauma arm would fall down. there is a potential that the c-arm could fall down onto the table and impact on the patient or bystander. the following factors are required for this situation to occur:- unusual wear and tear (e.G. multiple collisions)- there is more than one broken fixation screw and the user is unaware- operator is in contact with, moves, or operates the trauma arm- a person is situated below the trauma arm.
  • Action
    A Philips Service Engineer will contact affected customers as soon as the Field Action Kit is ready to be implemented. Philips is recommending the customers not to position the ceiling suspension with the Trauma arm directly above a patient until Philips Service Engineer repairs the affected systems. This action has been closed-out on 06/09/2016.

Device

Philips Trauma Diagnost X-ray SystemsAll Trauma Diagnost systems delivered prior to 8th of July 2...
  • Model / Serial
    Philips Trauma Diagnost X-ray SystemsAll Trauma Diagnost systems delivered prior to 8th of July 2007 are affected.ARTG Number: 100344
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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