Events

Field Safety Notices about Leica-microscoopsysteem M525 F20

According to Inspectie Gezondheidszorg en Jeugd, this field safety notices involved a device in Netherlands that was produced by Leica Microsystems.

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
    2018-08-20
  • Event Country
    Netherlands
  • Event Source
    IGJ
  • Event Source URL
    https://www.igj.nl/onderwerpen/waarschuwingen-medische-hulpmiddelen/documenten/waarschuwingen/2018/08/20/leica-microsystems-capa-her-md-18-001---leica-microscoopsysteem-m525-f20
  • Notes / Alerts
    The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, 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 the Netherlands.
  • Extra notes in the data
  • Reason
    Leica microsystems received five complaints from customers, in which users unintentionally tipped their leica m525 f20 microscope system. in four cases it was confirmed that the problem occurred when users used the microscope while the swivel arm was fully extended (see figure 3).

Device

Leica-microscoopsysteem M525 F20

Manufacturer

Leica Microsystems