Events

Safety Alert for (A, C, W and SL) - Registered at ANVISA under the respective numbers: 80047300067, 80047300061 and 80047300050. Serial numbers affected: all equipment of the models cited between January 2007 and December 2008.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Medstar Importação e Exportação Ltda; Pyramid Medical Systems Comércio 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
    976
  • Date
    2009-08-05
  • 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 holder of the product registration in Brazil, the X-ray beam disconnection occurs effectively after the end of the examination procedure, or after a predetermined number of minutes, by the equipment safety system. The authorized distributor of the Pyramid Medical Systems Commerce Ltda product has already initiated field action to correct the problem by sending a new software version for the equipment, which corrects the problem of uncontrolled X-ray emission. Tecnovigilância is following this case.
  • Reason
    The equipment may show on the monitor that the x-ray beam has been switched off after the scan, but the source still remains on.
  • Action
    The actions recommended to users of the product are as follows: (1) Observe in your equipment inventory the existence of affected products; (2) Verify receipt of communication letter from record holder / authorized distributor regarding the problem; (3) If you have not received communication from the authorized registry / distributor, contact the same / s and request information about it; (4) The operator of the equipment must turn off the radiation by pressing an emergency button on the equipment, or exiting the application of the examination, in the system. The record holder of the product informed the Anvisa Technovigilance Unit that has already initiated the field action to correct the problem.

Device

(A, C, W and SL) - Registered at ANVISA under the respective numbers: 80047300067, 80047300061 an...

Manufacturer

Medstar Importação e Exportação Ltda; Pyramid Medical Systems Comércio Ltda
  • Source
    ANVSANVISA