Events

Recall of Siemens Ysio Max X-Ray system

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
    18427
  • Event Initiated Date
    2015-04-24
  • 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
    Images might be lost and corresponding acquisitions have to be repeated under the following circumstances:, 1. during an image recovery process on systems with portable detectors (max wi-d, max mini) the connection of the portable detector is sporadically not re-established., 2. if either the "undo" button on the rad subtask card or the "previous series" button on the image subtask card are pressed during image readout., 3. sporadically, during an automatic or a manual ris update. this may cause the deletion of the currently used study and all acquired images within this study.
  • Action
    Software to be upgraded

Device

Siemens Ysio Max X-Ray system
  • Model / Serial
    Model: , Affected: Version VE10E
  • Manufacturer
    Siemens AG

Manufacturer

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