Events

Recall of Acuson 2000 ultrasound system (with structural foam core).

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Siemens Healthcare 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-2016-RN-00360-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-03-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00360-1
  • 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
    The metal component used to engage the lock on the wheels may disconnect, preventing the user from locking and unlocking or steering the wheels.In the event this issue occurs when the wheels are in the “unlocked” position and the user attempts to move the system, the user may lose balance. if the wheels are in the “locked” position and the user attempts to move the system, the user may sustain soft tissue damage or strain. to date, no patient injury has been reported.
  • Action
    Siemens is advising that there are no known steps the user can take to prevent the issue from occurring. Siemens will be modifying the wheel assembly on affected systems as a permanent correction.

Device

Acuson 2000 ultrasound system (with structural foam core).
  • Model / Serial
    Acuson 2000 ultrasound system (with structural foam core).Catalogue Number: 10433816ARTG Number: 139591
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Manufacturer Parent Company (2017)
    Siemens AG
  • Source
    DHTGA