Events

Recall of Philips Model AFFINITI 70 Ultrasound System Versions 1.0.2 or lower with Pediatric Cardiology option(Intended for diagnostic ultrasound imaging and fluid flow 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-2015-RN-00410-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-05-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00410-1
  • 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 affiniti 70 ultrasound system is set up to ‘metric’ and weight and/or height is entered, a unit conversion error may result in the incorrect calculation of the patient’s body surface area (bsa). using patient’s weight only to calculate the bsa, which is the usual practice for patients under the age of 2 years, would result in a value that is too high by a factor of about 1.7. a cardiac index calculated using that value would be too low by a factor of 1.7. an error of this magnitude may not be readily detected by the user.If a healthcare provider makes a clinical decision on the basis of a cardiac index calculated using an incorrect bsa without considering other indicators of cardiac function, misdiagnosis and/or delayed or incorrect therapy may result.
  • Action
    Philips has corrected this issue in software version 1.0.3. which will be provided to users free of charge. Philips has provided work around instructions for end users to use until the software update is provided. This action has been closed-out on 09/08/2016.

Device

Philips Model AFFINITI 70 Ultrasound System Versions 1.0.2 or lower with Pediatric Cardiology opt...
  • Model / Serial
    Philips Model AFFINITI 70 Ultrasound System Versions 1.0.2 or lower with Pediatric Cardiology option(Intended for diagnostic ultrasound imaging and fluid flow analysis)ARTG Number: 93851
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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