Events

Recall of Siemens AXIOM Artis, Artis zee and Artis Q/Q

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
    19817
  • Event Initiated Date
    2016-03-01
  • 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
    Due to a leak in the cooling system, fluids could seep into the equipment cabinet. this leak can occur sporadically in the affected systems., manufacturer initiated two field safety corrective actions (ax004/15/s und ax060/15/s) to address the issues with two different vendors for detector cooling devices. as the issues are identical, locally manufacturer sending both letters with one cover letter to all affected customers (this will prevent confusion among customers that have multiple systems and were required to receive both letters). each affected system will receive only one correction depending on the system type.
  • Action
    Product to be modified

Device

Siemens AXIOM Artis, Artis zee and Artis Q/Q
  • Model / Serial
    Model: 7555365,10094141,10094139,10094137,10094135,10280959,10848281,10848280,10848282,7413078,7412807,7008605,10848355,7728392,7555357,7727717, Affected:
  • Manufacturer
    Siemens AG

Manufacturer

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