Events

Safety Alert for Angix Digital Angiography System, record 80260940003, risk class III. Series Affected: SEE ANNEX.

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

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
    1624
  • Date
    2015-07-02
  • 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
    Dropping the arm may result in patient injury, operator or loss of interventional imaging.
  • Reason
    According to the information of the registration holder during movement of the shaft / flange joint the arm assembly c disconnects and may fall.
  • Action
    The company will correct the affected parties. It is recommended by the holder that the establishments stop using the Angix system until an inspection is performed by XPRO.

Device

Angix Digital Angiography System, record 80260940003, risk class III. Series Affected: SEE ANNEX.

Manufacturer

XPRO Sistemas LTDA.
  • Source
    ANVSANVISA