Events

Field Safety Notices about SAT XS32 12 SPE flat screen holders

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.

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 detected that remnants of the manufacturing process may be present on your product. based on our research covering worst case scenarios, we have come to the conclusion that there is little chance of these particles causing postoperative infection if they fall into a patient's wound or into sterile equipment.

Device

SAT XS32 12 SPE flat screen holders
  • Model / Serial
    500002 500003 500004 500005 500006 500007
  • Manufacturer
    Maquet

Manufacturer

Maquet
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    AMPMDRS