Events

Field Safety Notices about Main Connection Cable

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 Hocoma AG.

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
    2015-10-29
  • 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
    In a few main connection cables, routine testing has found that an important integrated ground wire was not always made correctly. under certain circumstances, this may cause a serious threat to your patients, users and third parties. for this reason, we have decided to launch a recall campaign and replace possibly affected cables. .

Device

Main Connection Cable

Manufacturer

Hocoma AG
  • Manufacturer Parent Company (2017)
    Hocoma Ag
  • Source
    AMPMDRS