Events

Recall of Philips Model EPIQ 5 Ultrasound System with Versions 1.3.2 or lower with Pediatric Cardiology option

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-00392-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-05-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00392-1
  • 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
    When epiq 5 ultrasound system is set up to ‘metric’ and weight and/or height is entered, a unit conversion error may occur which results in the incorrect calculation of the patient’s body surface area (bsa). when using both height and weight to calculate the bsa which is the usual practice for patients above the age of 2 years an error factor of about 10 may be applied which would be readily identified by the user.Alternatively, when using weight only the bsa may be out by a factor of about 1.7 which is much harder to detect as a cardiac index calculated using that value may not be as obvious to the user. however it is highly unlikely that this type of calculation would be used for patients older than 2 years of age. therefore, the risk of this error occurring is greatest when the bsa is calculated using weight only in patients under 2 years of age.
  • Action
    Philips has corrected this issue in software version 1.3.3. which will be provided to users free of charge.

Device

Philips Model EPIQ 5 Ultrasound System with Versions 1.3.2 or lower with Pediatric Cardiology option
  • Model / Serial
    Philips Model EPIQ 5 Ultrasound System with Versions 1.3.2 or lower with Pediatric Cardiology optionARTG number: 93851
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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