Events

Recall of Hologic Altec Canister Lid

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
    20495
  • Event Initiated Date
    2016-08-11
  • 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
    Some of the lids of one particular lot of atec canisters may have cracks and therefore this specific lot number is being recalled, the issue will be discovered during the inspection of the canister during the setup or via a system vacuum error when testing the eviva or atec biopsy needle. this issue does not pose any potential patient harm or other safety issue. however, it may prevent the system from enabling a procedure to continue.
  • Action
    Product to be returned to supplier

Device

Hologic Altec Canister Lid
  • Model / Serial
    Model: , Affected: Lot No: 20150013
  • Manufacturer
    Hologic Inc

Manufacturer

Hologic Inc