Events

Recall of Siemens Mammomat Fusion/Inspiration

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

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
    21016
  • Event Initiated Date
    2017-01-16
  • 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
    The manufacturer has become aware of potential errors that may occur while performing a biopsy. the system may freeze and the biopsy functionality may become not available in the following situations:, a) drop of the compression force, e.G. this may occur due to a patient sudden movement during the active targeting phase., b) or use of the inversion tool while the scout image is active during the targeting phase.
  • Action
    Manufacturer to issue advice regarding use

Device

Siemens Mammomat Fusion/Inspiration
  • Model / Serial
    Model: , Affected: 10140000 with software version VB30 and with a Biopsy option
  • Manufacturer
    Siemens Healthcare GmbH

Manufacturer

Siemens Healthcare GmbH
  • Manufacturer Parent Company (2017)
    Siemens AG
  • Source
    NZMMDSA