Events

Recall of Hologic Mini C-arm

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Hologic 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
    14588
  • Event Initiated Date
    2013-06-06
  • 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: Pharmaco (NZ) Ltd, Level 1, 4 Fisher Crescent, Mt Wellington, AUCKLAND 1060
  • Reason
    Manufacturer has identified the following compliance issues:, 1.The audible alarm to alert the operator when cumulative irradiation time reaches five minutes is not accurate., 2. the total cumulative irradiation time display is not accuarate., both issues are caused by computational error which truncates the fractions of seconds after each image and therefore the time to alarm and the time displayed are shorter by the sum of these fractions., this non-compliance does not pose a health hazard, as the radiation exposure to a patient depends on power settings during the procedure. the system provides the user with accurate dose to the patient information by displaying air kerma and cumulative air kerma.
  • Action
    Software to be upgraded

Device

Hologic Mini C-arm
  • Model / Serial
    Model: InSight and InSight 2, Affected:
  • Manufacturer
    Hologic Inc

Manufacturer

Hologic Inc