Events

Safety Alert for Commercial Name: CT Scanning System / Ingenuity CT. Technical name: CT Scanner / Computerized Tomography Scanner. ANVISA registration number: 10216710191. Class of risk: III - High Risk. Affected Models: Brilliance CT 6-Slice / Brilliance CT 64-Slice / Brilliance iCT / Brilliance iCT / Brilliance iCT / Brilliance CT 16-Slice / Ingenuity CT / Ingenuity Flex. Series Affected: See below

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Philips Medical Systems Ltda.; Philips Medical Systems Nederland B.V.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    2021
  • Date
    2016-09-13
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Extra notes in the data
    The Radiologist or physician should be aware of the fact that if they do not recognize the CT number deviation and the image artifacts resemble the patient's history, in the most severe cases, this problem can lead to misdiagnosis. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link
  • Reason
    When performing skull examinations in high resolution, the reconstructed images may exhibit degraded quality, which is manifested as: - lack of image uniformity; - deviation in ct number, greater than 5 units of hounsfield; - reduction of gray / white matter differentiation. the problem is more pronounced in high resolution mode. philips offers reference protocols for pediatric exams which are factory set for high resolution by default. for skull exams in adults, there is a factory reference protocol, set to normal resolution, which is not affected by the problem.
  • Action
    Field Action Code FCO72800666 triggered under the responsibility of the company Philips Medical Systems Ltda. Field Correction: Software update.

Device

Commercial Name: CT Scanning System / Ingenuity CT. Technical name: CT Scanner / Computerized Tom...

Manufacturer

Philips Medical Systems Ltda.; Philips Medical Systems Nederland B.V
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    ANVSANVISA