Events

Field Safety Notices about VESA 75 / 100 adaptation with rotation

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 ITD GmbH.

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
    We have within the framework of our ongoing quality checks unfortunately ascertained that in the case of the article "vesa 75 / 100 adaptation with rotation", which is part of our monitor mounts and support arms, the riveting of the rotation may possibly not have been carried out according to the specifications. in exceptional cases, it can lead to a loosening thereof, respectively to a loosening of the connection plate in the case of continuous use, which can in turn lead to a risk to patients, users or third parties. for this reason we have decided to carry out a replacement action. on account of the fact that no case of damage has hitherto occurred in practice, this relates to preventive measure with regard to our deliveries, for the limited time period from may to november 2015. based on our records, we have discerned that you have been supplied by us, with the affected products, during the aforementioned time period. a detailed list of relevant orders can be found in an annex to this letter. .

Device

VESA 75 / 100 adaptation with rotation

Manufacturer

ITD GmbH
  • Manufacturer Parent Company (2017)
    Itd Gmbh
  • Source
    AMPMDRS