Events

Recall of ACUSON S2000 and ACUSON S3000 Ultrasound Systems (software version VC25) or with HELX Evolution (software version VC30A)

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-2014-RN-00563-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-05-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00563-1
  • 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
    When using the 9l4 transducer in combination with virtual touch quantification (vtq), the displayed mechanical index (ie, the ml value which reflects the risk of mechanical cavitation that could cause tissue damage) may be outside the stated tolerance of +/=15%. this occurs only between the depths of 2.5cm and 3.4cm. to date, no patient injury has been reported.
  • Action
    Users are advised that the MI values should be interpreted as relative information and used only to assist the operators in implementing the ALARA (As Low As Reasonably Achievable) principle during patient examinations. For systems with software version VC25, Siemens is updating the Instructions for Use regarding the tolerance of the Mechanical Index (MI) displayed values. For systems with software version VC30A, Siemens is updating the software. This action has been closed-out on 18/02/2016.

Device

ACUSON S2000 and ACUSON S3000 Ultrasound Systems (software version VC25) or with HELX Evolution (...
  • Model / Serial
    ACUSON S2000 and ACUSON S3000 Ultrasound Systems (software version VC25) or with HELX Evolution (software version VC30A)Catalogue numbers: 10041461, 10440017 and 10441730ARTG Number: 137563
  • Manufacturer
    Siemens Ltd

Manufacturer

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