Events

Safety Alert for OPTIMUS CP X-RAY GENERATOR FIRMWARE: (1) VERSION 7.X, (2) VERSION 8.1, (3) VERSION 8.2, (4) VERSION 8.3. IDENTIFIER: UNITS PROVIDED IN VASCULAR SYSTEMS INTEGRIS (VASCULAR INTEGRIS SYSTEMS) IN COMBINATION OF AN X-RAY TUBE MRM 04/10 AND AN OPTION

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
    109
  • Date
    2001-02-16
  • 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
    If bolus works in the above systems, the injector may inject the means of contrast without performing the desired exposure. distributor started a change correction on field on february 16, 2001.
  • Action
    MAKE SURE THAT YOUR SYSTEM HAS BEEN MODIFIED BY PHILIPS MEDICAL SYSTEMS NORTH AMERICA. IF YOUR SYSTEM HAS NOT BEEN MOLDED, OR FOR FURTHER INFORMATION, PLEASE CONTACT YOUR PHILIPS MEDICAL SYSTEMS NORTH AMERICA REPRESENTATIVE.

Device

OPTIMUS CP X-RAY GENERATOR FIRMWARE: (1) VERSION 7.X, (2) VERSION 8.1, (3) VERSION 8.2, (4) VERSI...

Manufacturer

PHILIPS MEDICAL SYSTEMS NORTH AMERICA
  • Source
    ANVSANVISA