Events

Field Safety Notices about Brilliance a Ingenuity

According to Ministry of Health, State Institute for Drug Control, Coordination Center for Departmental Medical Information Systems, this field safety notices involved a device in Czechia that was produced by Philips Healthcare.

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
    866
  • Date
    2016-11-29
  • Event Country
    Czechia
  • Event Source
    MHSIDCCCDMIS
  • Event Source URL
    https://eregpublicsecure.ksrzis.cz/Registr/RZPRO/FSN
  • Notes / Alerts
    Czech data is current through July 2018. All of the data comes from the Czech Public Registry of Medical Devices, 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 data from the U.S. and the Czech Republic.
  • Extra notes in the data

Device

Brilliance a Ingenuity
  • Model / Serial
    Catalog Number: Brilliance BR64 CT -- NCTB423 Ingenuity Core -- NCTD321 Ingenuity Core128 -- NCTD311 Ingenuity CT -- N/A Brilliance 16 -- NCTA399 Brilliance 16P –NCTA401 Ingenuity Core -- NCTD321 Ingenuity Core128 -- NCTD311 Brilliance CT Big Bore -- NCTB104/NCTB604 Brilliance 40 – NCTA402 Brilliance 10 – NCTA397 Brilliance iCT SP –N/A Brilliance iCT – NCTC780 Model Number: Brilliance iCT SP: 728311 Brilliance iCT: 728306 Brilliance 64: 728231 Brilliance 40: 728235 Brilliance 16: 728246 Brilliance 16P: 728240 Brilliance 10: 728251 Brilliance 6: 738256 Brilliance Big Bore Oncology: 728243, Brilliance Big Bore Radiology: 728244 Ingenuity Core 728321 Ingenuity Core128 728323 Ingenuity CT 728326
  • Product Description
    Medical devices for diagnostics and radiation therapy
  • Manufacturer
    Philips Healthcare

Manufacturer

Philips Healthcare
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    MHSIDCCCDMIS