Events

Safety Alert for SOMATOM DEFINITION AS and SOMATOM DEFINITION FLASH Technical Name: CT Scanning Equipment ANVISA Registration Number: 10234230157 Hazard Class: III Model Affected: SOMATOM DEFINITION AS and SOMATOM DEFINITION FLASH Serial numbers affected: 64127; 64147; 64584; 64665; 64948; 64981; 64988; 65055; 65160; 65227; 65395; 65405; 65422; 65431; 65477; 65571; 65584; 65585; 65621; 65648; 65675; 65682; 65901; 65910; 65950; 65987; 66149; 66397; 66401; 66430; 66479; 66488; 66492; 66524; 66584; 66586; 66590; 66782; 73105; 73172.

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 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
    2087
  • Date
    2016-10-31
  • 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 operator must not use the CT system if the laser marker window is not present or is loose. In addition, please inform the Siemens Service Center.
  • Reason
    Siemens has identified that in rare cases the small window of the light marker used for the positioning laser and integrated into the front cover of the ct system may become loose and possibly fall.
  • Action
    Field Action Code CT031 / 16 / S triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will send Letter to the Client.

Device

SOMATOM DEFINITION AS and SOMATOM DEFINITION FLASH Technical Name: CT Scanning Equipment ANVISA R...

Manufacturer

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