Events

Field Safety Notices about Mammomat Inspiration system with software version VB30 and Biopsy functionality

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

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
    2017-01-13
  • Event Country
    Netherlands
  • Event Source
    IGJ
  • Event Source URL
    https://www.igj.nl/onderwerpen/waarschuwingen-medische-hulpmiddelen/documenten/waarschuwingen/2017/01/13/field-safety-notice-siemens---mammomat-inspiration-system-with-sw-vb30-and-biopsy-functionality
  • 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
    Siemens has become aware of potential errors that may occur while performing a biopsy. the system may freeze and the biopsy functionality may become not available in the following situations: 1. drop of the compression force, e.G. this may occur due to a patient sudden movement during the active targeting phase. 2. or use of the inversion tool while the scout image is active during the targeting phase.

Device

Mammomat Inspiration system with software version VB30 and Biopsy functionality
  • Model / Serial
  • Manufacturer
    Siemens

Manufacturer

Siemens
  • Manufacturer Parent Company (2017)
    Siemens AG
  • Manufacturer comment
    Note published by the authorities from the Netherlands: This message is a warning from the manufacturer. After placing a medical device on the market, the manufacturer is obliged to follow the device and, where necessary, to improve it. When there is a risk for the user, the manufacturer must take action. The manufacturer informs users and the inspection of this action with a warning (Field Safety Notice). See also medical device warnings. This is part of the supervision of medical technology.
  • Source
    IGJ