Events

Safety Alert for X-ray Systems for Brilliance Computed Tomography. Anvisa Record: 10216710191. Potentially Affected Models: Brilliance 6, 10, 16, 16P, 40, 64, Big Bore, iCT, iCT SP.

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

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
    1057
  • Date
    2011-04-27
  • 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 the problem is identified, a Mandatory Safety Modification Order to repair the vertical braking center on the patient's desk will be issued by Philips, free of charge. The Safety Service Engineer will perform a rework of the system's braking center to solve the problem. If any additional information or support is required regarding this matter, contact your local Philips representative or Philips local health office - Customer Service Solutions Center (Tel .: 0800-701-77-89). Additional information can be found at http://portal.anvisa.gov.br/wps/wcm/connect/1773018046a71ce891fe95c9c474c85c/Carta+a++clients.pdf?MOD=AJPERES
  • Reason
    Failure in the vertical bracket of the patient bracket can cause the equipment table to break.
  • Action
    If a failure of this type is observed, the system should no longer be used and the product registration holder (Philips Medical System Ltda.), Or its nearest representative, should be notified of the problem.

Device

X-ray Systems for Brilliance Computed Tomography. Anvisa Record: 10216710191. Potentially Affecte...

Manufacturer

Philips Medical Systems
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    ANVSANVISA