Events

Recall of SonoSite NanoMaxx Ultrasound System, version 60.80.101.025

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Fujifilm Sonosite Australasia 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-2012-RN-01159-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-11-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01159-1
  • 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
    During design verification testing, it was found that when using its nanomaxx ultrasound system configured with system software arm version 60.80.101.025 (referred to as nano 1.0.5) when the usb printer is selected from the pull down menu and the print command is selected, the status bar will freeze as expected during spooling. however, once the spooling is complete the status car does not unfreeze and information is not updated.
  • Action
    Customers to contact SonoSite Technical support to arrange a software upgrade.

Device

SonoSite NanoMaxx Ultrasound System, version 60.80.101.025

Manufacturer

Fujifilm Sonosite Australasia Pty Ltd