Field Safety Notices about ct computer tomographs brillance 64 and ct ingenuity with software version 3.5.1.

According to Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, this field safety notices involved a device in Poland that was produced by Philips.

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 ID
    1140
  • Date
    2012-04-12
  • Event Country
  • Event Source
    ORMPMDBP
  • Event Source URL
  • Notes / Alerts
    Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 Poland.
  • Extra notes in the data
  • Action
    A Philips safety note regarding the Brillance 64 and CT Ingenuity CT scanners with software version 3.5.1.

Manufacturer

  • Manufacturer Parent Company (2017)
  • Source
    ORMPMDBP