Events

Safety Alert for Allura Xper Angiography Equipment Technical Name: Angiography Equipment ANVISA Registration Number: 10216710153 Hazard Class: III Model Affected: ALLURA XPER FD10 OR table; ALLURA XPER FD20 OR table; ALLURA XPER FD10 (ground); ALLURA XPER FD10 (ceiling); ALLURA XPER FD20 (ground); ALLURA XPER FD20 (ceiling) Serial numbers affected: 01H025418

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
    2191
  • Date
    2016-12-19
  • 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, after receiving the "Fluoroscopy / Exposure canceled, try again" message, repeat fluoroscopy or exposure is unsuccessful, the system must be restarted with a cold or warm restart. If a cold or hot restart is unsuccessful, contact your local Philips dealer.
  • Reason
    With the velara generator with an old firmware version, after receiving the message "fluoroscopy / exposure canceled, try again" try to repeat the fluoroscopy or the exposure will not be successful and the system will be blocked. the system lock can only be solved by resetting the system hot or cold. in exceptional cases, the velara generator will be damaged and the system can not be restarted.
  • Action
    Field Action Code 2016-IGTBST-006 triggered under the responsibility of the company Philips Medical Systems Ltda. Company will make correction in the field.

Device

Allura Xper Angiography Equipment Technical Name: Angiography Equipment ANVISA Registration Numbe...

Manufacturer

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