Events

Recall of ACUSON S Family Ultrasound Systems utilising the 18L6 HD and/or 6C1 HD biopsy guidelines

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-2015-RN-00609-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-07-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00609-1
  • 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
    This issue occurs when using the civco biopsy attachments in combination with the acuson s family on-screen guidelines. the biopsy needle may traverse outside the on-screen guidelines. this occurs on the 6c1 hd and 18l6 hd transducers. the potential risk is the tissue of interest may not get sampled. to date, no patient injury has been reported.
  • Action
    To avoid this issue, users are advised not to use the 6C1 HD and 18L6 HD with the CIVCO biopsy attachments for guided biopsy procedures. For guided procedures with other transducers, users are advised that they must verify that the path of the needle is accurately indicated by the on-screen guidelines. The needle guide is ready for patient use only after the path of the needle has been verified. Also, users are reminded of the following warnings: - The biopsy guidelines that display on the system monitor are not intended as an absolute reference. It is the user's responsibility to verify correct positioning of the needle during a biopsy or puncture procedure. - Do not use a needle guide if the path of the needle is not accurately indicated by the on-screen guidelines. The path of the needle must display within the guideline. Users are advised to contact their Siemens service representative if the needle path is not accurately indicated.

Device

ACUSON S Family Ultrasound Systems utilising the 18L6 HD and/or 6C1 HD biopsy guidelines
  • Model / Serial
    ACUSON S Family Ultrasound Systems utilising the 18L6 HD and/or 6C1 HD biopsy guidelinesCatalogue numbers – 10041461, 10441701, 10441730ARTG Number: 137563
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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