Events

Recall of EPIQ 7 Diagnostic Ultrasound System (software version 1.0, 1.0.1)

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-01085-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-10-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01085-1
  • 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
    Under system settings, if the system date format is set to international, dd/mm/yyyy, the system continues to interpret the date as mm/dd/yyyy on the patient data entry (pde) screen. the anomaly exists in date fields for ‘last menstrual period’ (lmp), ‘established due date’ (edd) and ‘conception date’. the lmp field is presented in four exam types: obstetric (ob,) fetal echo, gynaecology (gyn), and breast and populates from one exam type to the other.
  • Action
    Philips is advising users that the issue can be avoided by making sure the system is set to the default setting of MM/DD/YYYY. A Philips Field Service Engineer will contact customers to schedule a software update to correct the issue.

Device

EPIQ 7 Diagnostic Ultrasound System (software version 1.0, 1.0.1)

Manufacturer

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