Events

Safety Alert for Product Category: Angiography Equipment Allura Xper. Registration number ANVISA: 10216710153. Class of risk: III. Allura Xper FD1O / Allura Xper FD1O / 10 Allura Xper FD2O / Allura Xper FD2O / Allura Xper FD2O / Allura Xper FD1O / Allura Xper FD1O / Allura / Allure Xper FD2O / 1 / Allura Xper FD2O / 1 5 OR Table. List of lots / series: 285/306/308/322/379/565/405/639

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
    1970
  • Date
    2016-06-23
  • 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
    If you have any questions regarding this action, please contact Philips by phone: 0800 701 7789
  • Reason
    Philips healthcare has discovered, by means of trend analysis, an increase in the error rate of certain low voltage dc ("facc") power supplies used in these products. each system contains multiple faccs, some of which may be subject to a high probability of error. failure of a facc may result in the sudden loss of image acquisition or mechanical motion functionality, depending on which subsystems the facc is feeding. the severity was classified as resulting in severe injury: life threatening or permanent damage or need medical intervention to avoid permanent damage. the probability of occurrence was classified as possible but unlikely. the conclusion of the risk analysis was not acceptable.
  • Action
    Field action FCO72200371 Sending letter to clients (attached) // FACC replacement affected.

Device

Product Category: Angiography Equipment Allura Xper. Registration number ANVISA: 10216710153. Cla...

Manufacturer

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