Events

Safety Alert for Fluoroscopic X-ray System Diagnostic 94. Anvisa Registry n ° 10216710016.

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

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
    1102
  • Date
    2011-12-05
  • 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
    According to the company, the instructions for using the equipment already inform the correct way of positioning the patients. Operators of the equipment should be aware of this by observing the position of the apparatus with respect to the legs of the patients.
  • Reason
    Possibility of fracture in the lower limbs of patients, due to incorrect positioning of the same.
  • Action
    Philips Healthcare Brazil has already begun communicating with customers through letters to users.

Device

Fluoroscopic X-ray System Diagnostic 94. Anvisa Registry n ° 10216710016.

Manufacturer

Philips Healthcare Brazil.
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    ANVSANVISA