Events

Recall of Siemens Biograph mMR PET/MRI

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

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
    19605
  • Event Initiated Date
    2015-12-23
  • 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 manufacture confirms that in some cases the quench lines for some superconducting magnets may have not been properly installed and wants to alert the users to check if the quench lines for their systems have been installed under safe conditions. siemens in new zealand will inspect all quench lines installed by siemens., quench lines are installed to vent helium gas in the event of a quench. (quenching refers to the events that occur when the liquid cryogens that cool the magnet coils boil off rapidly, which results in helium escaping very rapidly from the cryogen bath) in the rare event of a quench an improperly installed quench line may cause the helium gas to be blown directly into the magnet room or other areas.
  • Action
    Product to be modified

Device

Siemens Biograph mMR PET/MRI
  • Model / Serial
    Model: 10433372, Affected:
  • Manufacturer
    Siemens AG

Manufacturer

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