Events

Recall of ACUSON S2000 Automated Breast Volume Scanner (ABVS)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Siemens 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-00079-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-01-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00079-1
  • 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
    On some acuson s2000 abvs systems, the edges on the inside of the transducer pod may not have been completely deburred to avoid sharp edges.
  • Action
    A Siemens Service Engineer will perform an onsite inspection to determine if burrs are present on your device. The service engineer will remove any burrs if present.

Device

ACUSON S2000 Automated Breast Volume Scanner (ABVS)
  • Model / Serial
    ACUSON S2000 Automated Breast Volume Scanner (ABVS)ARTG Number: 137563
  • Manufacturer
    Siemens Ltd

Manufacturer

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