Events

Recall of Philips Ultrasound QLAB

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
    17044
  • Event Initiated Date
    2014-07-28
  • 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
    Manufacturer advise of a problem with the philips ultrasound qlab that could result in the erroneous caculation of ejection fraction (ef) from the results of using a2dq and acmq patient exams.This miscalculation can only occur in qlab versions 10.0 and 10.1 on a pacs or with thiurd party pacs integration.
  • Action
    Software to be upgraded

Device

Philips Ultrasound QLAB
  • Model / Serial
    Model: 453561704771 and 45356182801, Affected: , Software version: 10.0 amd 10.1
  • Manufacturer
    Philips Ultrasound

Manufacturer

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