Events

Recall of Philips MX 16-slice CT systems featured with Lung Nodule Analysis

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-2016-RN-01603-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-12-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01603-1
  • 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
    The formula of doubling time is incorrectly defined in lung nodule analysis (lna). this may result in the wrong calculation result of doubling time, which may lead to misdiagnosis. lna is an optional tool that is only featured on mx 16-slice systems with software version 2.0.
  • Action
    Philips will upgrade the system software and replace the software discs free of change. Before the software is upgraded, customers are advised not to refer to the parameter of “Doubling Time [day]” in Lung Nodule Analysis, instead refer to the parameter “Growth Rate [%]” for the growth of nodules.

Device

Philips MX 16-slice CT systems featured with Lung Nodule Analysis
  • Model / Serial
    Philips MX 16-slice CT systems featured with Lung Nodule AnalysisSerial numbers: 100006, 200019, 200065, 200001, 200021, 200067, 200002, 200022, 200071, 200009, 200023, 200079, 200011, 200026, 200083, 200014, 200029, 200084, 200016, 200035, 200090, 200017, 200059, 200092, 200018, 200062, 200078ARTG Number: 158775
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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