Events

Recall of Philips AFFINITI 70 Ultrasound System, without Pediatric Cardiology option

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Philips Ultrasound.

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
    18526
  • Event Initiated Date
    2015-05-15
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Philips New Zealand Commercial Limited, Level 3, 123 Carlton Gore Road, Newmarket, AUCKLAND 1023
  • 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.
  • Action
    Software to be upgraded

Device

Philips AFFINITI 70 Ultrasound System, without Pediatric Cardiology option
  • Model / Serial
    Model: AFFINITI 70, Affected: , Software version: 1.0.2 or lower without the Pediatric Cardiology
  • Manufacturer
    Philips Ultrasound

Manufacturer

Philips Ultrasound
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    NZMMDSA