Events

Recall of Siemens Acuson Ultrasound System, utilising the 6C1 HD and/or 18L6 HD biopsy guidelines

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Siemens Medical Solutions USA Inc.

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
    18820
  • Event Initiated Date
    2015-07-08
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Siemens Healthcare (NZ) Ltd, Millennium Centre, Part Level 2, Building A, 600 Great South Road, Ellerslie, AUCKLAND 1051
  • Reason
    Siemens advises that the 6c1 hd and 18l6 hd transducers demonstrate a misalignment while utilising the on-screen guidelines. 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.
  • Action
    Manufacturer to issue advice regarding use

Device

Siemens Acuson Ultrasound System, utilising the 6C1 HD and/or 18L6 HD biopsy guidelines

Manufacturer

Siemens Medical Solutions USA Inc
  • Manufacturer Parent Company (2017)
    Siemens AG
  • Source
    NZMMDSA