Events

Recall of Biograph m CT and Biograph m CT Flow Combination PET/CT

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

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
    20969
  • Event Initiated Date
    2016-12-21
  • 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, through our supplier that some laser cover windows may fall off. due to the subsequent gantry cover opening, there is a potential for injury if a patient, operator or other person reaches into this gantry opening.
  • Action
    Manufacturer to issue advice regarding use

Device

Biograph m CT and Biograph m CT Flow Combination PET/CT
  • Model / Serial
    Model: , Affected: Lot number: 10248668, 10248669, 10248670, 10248671, 10248672, 10248673, 10250743, 10250745, 10507786, 10528955, 10529159
  • Manufacturer
    Siemens Medical Solutions USA Inc

Manufacturer

Siemens Medical Solutions USA Inc
  • Manufacturer Parent Company (2017)
    Siemens AG
  • Source
    NZMMDSA