Events

Recall of MultiDiagnost Eleva Flat Detector (FD) System(Diagnostic fluoroscopic digital 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-2015-RN-00070-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-01-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00070-1
  • 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 healthcare has discovered through customer complaints and internal testing an intermittent electronic product defect. in the md eleva system, software license keys are used to enable particular functionality. in software release r6.1.1sp2 and r6.1.2 intermittently part of the software keys are not loaded: - the license key for spectral filter- the license key for full table tilt range.
  • Action
    Philips Healthcare is recommending a system restart that may solve both issues when the software keys are not loaded. Philips Healthcare is providing the following instructions to identify the defects: If the license key for spectral filter is not loaded: once an EPX with half-dose is selected the incomplete dose reduction can be noticed via the actual skin dose (rate) displayed on the image monitor and the actual filter selection is displayed on the examination monitor. If the license key for full table tilt range is not loaded: The tilt movement stops at -20 degrees. This can be observed while preparing the room. Philips Healthcare released a software update and organising Philips field service engineers to install Software release R6.1.3 which addresses the non-loading of the Software license keys. This action has been closed-out on 08/08/2016.

Device

MultiDiagnost Eleva Flat Detector (FD) System(Diagnostic fluoroscopic digital X-ray system)
  • Model / Serial
    MultiDiagnost Eleva Flat Detector (FD) System(Diagnostic fluoroscopic digital X-ray system)Product Code: 708037ARTG Number: 98560
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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