Events

Recall of Siemens Acuson Ultrasound System

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
    21313
  • Event Initiated Date
    2017-04-10
  • 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
    When scanning with the 18l6 hd transducer on the acuson helx™ evolution with touch control, the ultrasound system may display a triple image or an image with a darkband. for the triple image issue, the system repeats one-third of the aperture, but does not display the full field of view.
  • Action
    Manufacturer to issue advice regarding use

Device

Siemens Acuson Ultrasound System
  • Model / Serial
    Model: , Affected: 18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C
  • Manufacturer
    Siemens Medical Solutions USA Inc

Manufacturer

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