Events

Recall of LOGIQ S8 with software revisions R1.1.1 and R1.5.1, and LOGIQ S7 with software revisions R1.0.1, R1.0.2 and R1.0.3 (Diagnostic ultrasound system)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by GE Healthcare Australia Pty 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-00370-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-04-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00370-1
  • 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
    There is a potential for a skin burn when the flow model in the cardiac application is activated with the s4-10-d ultrasound probe.
  • Action
    GE is advising customers to discontinue activation of the “Flow Model” in the Cardiac Application when used with the S4-10-D ultrasound probe and is correcting the affected units permanently with a software update.

Device

LOGIQ S8 with software revisions R1.1.1 and R1.5.1, and LOGIQ S7 with software revisions R1.0.1, ...
  • Model / Serial
    LOGIQ S8 with software revisions R1.1.1 and R1.5.1, and LOGIQ S7 with software revisions R1.0.1, R1.0.2 and R1.0.3 (Diagnostic ultrasound system)ARTG Number: 198951
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd