Events

Field Safety Notices about Disposable Reflective Marker Sphere

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 BRAINLAB.

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
  • Date
    2015-09-30
  • 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
    As an amendment to the recently distributed brainlab field safety notice we ask you to remove the remaining brainlab disposable reflective marker spheres (drms) of potentially affected lots from your inventory and from clinical use.

Device

Disposable Reflective Marker Sphere
  • Model / Serial
    1014213001 C103461502 C107761402 C100111501 C1034813001 C108341301 C101021502 C103881402 C108721402 C101161401 C104761402 C109051301 C101611502 C105541402 C109251402 C102311401 C106521402 C1098312001 C102481502 C106721301 C110411401
  • Manufacturer
    BRAINLAB

Manufacturer

BRAINLAB