Events

Recall of Siemens Digital Linear Accelerators of type MEVATRON, ARTISTE , PRIMUS, ONCOR and ARTISTE

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
    17913
  • Event Initiated Date
    2014-12-23
  • 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
    Manufacturer has received reports of one electric board (g41) located inside of the linac gantry showing signs of over heating. after a detailed analysis the root cause was found to be one of the components that belong to this board (head driver pcb). the manufacturer has redesigned the head driver pcb to further mitigate the risk of local over heating on the g41 motherboard. the present corrective action comprises the replacement of the head driver pcb on afected systems.
  • Action
    Product to be modified

Device

Siemens Digital Linear Accelerators of type MEVATRON, ARTISTE , PRIMUS, ONCOR and ARTISTE
  • Model / Serial
    Model: 08139789, 05864472, 05857912, 07360717, 05857920, 04504200, 01940035, 05500371, 09822685, 09411588, 09822693, 08515520, 01940753, 01924500, 09401506, 09401407, 09401316, 10941746 and 09401654, Affected:
  • Manufacturer
    Siemens AG

Manufacturer

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