Events

Safety Alert for Extracorporeal Lithotripsy Equipment MODULARIS Variostar - Modular Variostar Record nº 10234230180. Lots: 4021; 5016; 5030; 5094; 5101; 5107; 5126; 5147; 5188; 5191; 6016; 6035; 6038; 6055.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Siemens 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
    1703
  • Date
    2015-10-23
  • 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
    The company informs that if the MODULARIS system display hangs, there is a possibility that this will result in insufficient information for the treatment.
  • Reason
    Siemens healthcare has identified that on rare occasions, the modularis manual control display locks up and the information displayed on it is not updated. neither the amount of shock waves applied nor other parameters that have been changed by the user in the manual control will be displayed. this may result in insufficient information for treatment.
  • Action
    The company advises that whenever changes in parameters are made in the manual control of the MODULARIS, the user must make sure that the display is showing the new updated values. If the MODULARIS manual control display locks, stop the treatment immediately. Currently, the potential malfunction of the incorrect treatment data display can only be mitigated by the user when the user checks that the manual control display is showing the new values ​​updated after the parameters have been changed. Further information: Appendix II: Customer Letter Disconnect the MODULARIS manual control from the MODULARIS Variostar basic unit and reconnect it. The manual control will start automatically and display the correct values. Then treatment can continue.

Device

Extracorporeal Lithotripsy Equipment MODULARIS Variostar - Modular Variostar Record nº 1023423018...

Manufacturer

Siemens Ltda.
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    ANVSANVISA