Events

Recall of IBA Stealth Chamber DS50-0030XL-T

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

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
    21393
  • Event Initiated Date
    2017-05-01
  • 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: Alphatech Systems Limted, 630a Great South Road, Greenlane, Auckland
  • Reason
    When the stealth chamber is used as a reference detector in relative dosimetry, deviation in the measured pdds at shallow depths and geometric shadowing of measured profiles may appear.
  • Action
    Manufacturer to issue advice regarding use

Device

IBA Stealth Chamber DS50-0030XL-T
  • Model / Serial
    Model: , Affected: IBA DS50-003-XL-T Stealth Chamber
  • Manufacturer
    IBA Dosimetry GmbH

Manufacturer

IBA Dosimetry GmbH