Events

Safety Alert for MULTIDIAGNOST IMAGE INTENSIFIED FLUOROSCOPIC X-RAY SYSTEMS FLUOROSCOPIC X-RAY SYSTEMS: (1) MODEL 3, (2) MODEL 4. ALL SYSTEMS OF THESE CITED MODELS INSTALLED BEFORE MARCH 2000.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by PHILIPS MEDICAL SYSTEMS NORTH AMERICA.

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
    107
  • Date
    2000-10-20
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Reason
    The ankle clamp in the above systems can release the foot of the plate and make the x-ray table diminish. the distributor started a correction by notifying service representatives on october 20, 2000.
  • Action
    MAKE SURE THAT YOUR SYSTEM HAS BEEN MODIFIED BY PHILIPS MEDICAL SYSTEMS NORTH AMERICA. IF YOUR SYSTEM HAS NOT BEEN MODIFIED, OR FOR FURTHER INFORMATION, PLEASE CONTACT YOUR PHILIPS MEDICAL SYSTEMS NORTH AMERICA REPRESENTATIVE.

Device

MULTIDIAGNOST IMAGE INTENSIFIED FLUOROSCOPIC X-RAY SYSTEMS FLUOROSCOPIC X-RAY SYSTEMS: (1) MODEL ...

Manufacturer

PHILIPS MEDICAL SYSTEMS NORTH AMERICA
  • Source
    ANVSANVISA