Events

Recall of MX 16-Slice CT scanner

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-00012-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-01-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00012-1
  • 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 discovered that four screws that secure the patient table top to the carrier can become loose, causing the table top to detach.
  • Action
    Phillips Healthcare is advising hospitals and radiology centres to inspect the patient table top screws. If the screws are not properly seated, discontinue use of the device and contact a Philips Field Service Engineer for repair. Philips Healthcare will contact their customers to schedule a time to replace the screws for all affected systems.

Device

MX 16-Slice CT scanner
  • Model / Serial
    MX 16-Slice CT scannerSerial numbers: EP16E090006, EP16E110104, EP16E100082, EP16E120011, P16EM09002, EP16E100003ARTG Number: 158775
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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