Events

Safety Alert for Trade Name: FLUOROSCOPIC SYSTEM OF X-RAYS AXIOM Luminos dRF - 10345161987 - Class of risk III. Serial Numbers: 3141; 3142; 3144; 3174.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Siemens Healthcare Diagnósticos S.A; Siemens AG; Siemens Healthcare GmbH.

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
    1946
  • Date
    2016-06-16
  • 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
    Recommendations to Users and Patients: Users and patients may continue to use the system normally until the software update is performed by one of Siemens' technicians. And if there is any deviation in the operation of the equipment, it must be reported immediately to Siemens.
  • Reason
    Siemens healthcare sa informs that outdated software points to two problems: sporadic dosing failure and brake failure in the overload tube. there may be an out-of-specification dose during a test and the overload tube may swing down in the event that the equipment's current software does not activate the brakes. both problems will be fixed with the new software version.
  • Action
    Action code XP056 / 14 / S: Recommendations to users and patients ///// Software Update.

Device

Trade Name: FLUOROSCOPIC SYSTEM OF X-RAYS AXIOM Luminos dRF - 10345161987 - Class of risk III. Se...

Manufacturer

Siemens Healthcare Diagnósticos S.A; Siemens AG; Siemens Healthcare GmbH
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    ANVSANVISA