Events

Recall of Essenta DR X-ray System (Digital diagnostic X-Ray system)

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-2013-RN-01328-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-12-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01328-1
  • 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 during system installation, the screws holding the c-arm were mounted using thread locking compound (for example, loctite), then the corresponding thread inserts inside the c-arm casting may loosen when the c-arm is dismantled. if after reassembly of the system, the loosened thread inserts become detached from the casting, the c-arm would no longer securely held in position and could fall. the c-arm is most often dismantled and reassembled when the system is moved to another location.
  • Action
    Philips Healthcare is advising users to check the connection of the C-arm to the column to ensure the C-arm is parallel to the column in side view. If the C-arm is not parallel, do not use the system and contact Philips Healthcare. Philips Healthcare is inspecting all affected units and applying a safety label on affected systems. Local service manuals will be updated at each system site.

Device

Essenta DR X-ray System (Digital diagnostic X-Ray system)

Manufacturer

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