Events

Field Safety Notices about Accessory Adapter 600525A0

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 MAQUET 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
    With the investigation it was identified that the raw material of the accessory adapter (600525a0) does not meet maquets specifications. the tensile and the flexural strength of the used material are less than those of the specified materials furthermore it was identified that the accessory adapter (600525ao) does carry the specified weight of 11 kg at a distance of 300 mm, however does not meet our stringent quality requirements.

Device

Accessory Adapter 600525A0

Manufacturer

MAQUET GmbH
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    AMPMDRS