Events

Field Safety Notices about Halo Vest Lil Angel Halo Vest

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 Össur.

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
    2017-04-10
  • 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
    A halo vest naturally limits the accessibility to the chest in the event of an emergency situation, therefore we felt it important to send a safety alert reminding our valued össur customers of this risk. this alert explains how to properly remove an össur vest, as well as any additional actions required. in an effort to improve visibility of product removal instructions in the event of an emergency, össur has redesigned the emergency cpr access labeling for the össur halo and lil angel vests. in addition to improved visibility, the new label uses symbols that can be universally understood. .

Device

Halo Vest Lil Angel Halo Vest
  • Model / Serial
  • Manufacturer
    Össur

Manufacturer

Össur
  • Manufacturer Parent Company (2017)
    Össur hf
  • Source
    AMPMDRS