Events

Recall of EPIQ 7 Ultrasound system version 1.0 (Intended for diagnostic ultrasound imagingand 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-2013-RN-01011-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-09-25
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01011-1
  • 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
    A problem has been detected with philips model epiq 7 ultrasound system v1.0 when using philips qlab a2dq software feature. it is possible to have erroneous ejection fraction (ef) measurements appear in the biplane analysis report page under certain conditions while using a2dq. the biplane analysis report page could display ap2 or ap4 edv/esv/ef measurements from a prior patient’s exam. erroneous measurement information in the biplane analysis report page could mistakenly influence patient care. this issue only occurs on software version 1.0 in a2dq during a live (frozen) image and only when a single biplane view is included in the exam. when both biplane views are present (ap2 and ap4) this issue does not occur.
  • Action
    Philips corrected this issue in Version 1.01 of the EPIQ 7 Ultrasound System. A Philips Field Service Engineer will be contacting customers to schedule the V1.01 upgrade to affected systems. Philips is providing temporary workaround instructions to prevent the failure mode from occurring until the systems are upgraded.

Device

EPIQ 7 Ultrasound system version 1.0 (Intended for diagnostic ultrasound imagingand fluid flow an...
  • Model / Serial
    EPIQ 7 Ultrasound system version 1.0 (Intended for diagnostic ultrasound imagingand fluid flow analysis)ARTG Number: 93851
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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