Events

Recall of Radspeed Manual / Auto

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

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
    21549
  • Event Initiated Date
    2017-06-16
  • 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: Shimadzu Medical Systems NZ Ltd, 9B Clemway Place, Henderson, Auckland 1230
  • Reason
    It was found that a crack may occur over time on the tube holding shaft near the base of the tube mounting flange. if these cracks occur and then increase in size, the tube mounting flange may separate from the tube holding shaft.
  • Action
    Product to be modified

Device

Radspeed Manual / Auto
  • Model / Serial
    Model: , Affected: Tube Support, CH-200/CH-200M product range
  • Manufacturer
    Shimadzu Corporation

Manufacturer

Shimadzu Corporation