Events

Field Safety Notices about ATEC Sapphire Breast Biopsy System.

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Hologic, lnc..

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Extra notes in the data
  • Reason
    There have been reports of customers receiving atec canisters with cracked lids. we wanted to notify you that hologic is aware of the issue and we need your assistance resolving this problem. hologic inc. is recal ng certain lots of its atec canister. this ac n is being taken because the canister d may have cracks. the lot numbers affected by the reca are as follows: lot # 20150013 & 20150014. this issue will be discovered during the inspection of the canister during 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.

Device

ATEC Sapphire Breast Biopsy System.

Manufacturer

Hologic, lnc.