Events

Safety Alert for SOMATOM DEFINITION AS - Model 128-SLICES; 20-SLICES; 40-SLICES; 64-SLICES - Registration Number: 10345161981, Serial Number 66488

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 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
    1755
  • Date
    2015-11-20
  • 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 Siemens Healthcare is already analyzing the root cause of this problem and that it will develop a solution for it as soon as possible. In line with the principles of commitment to patient safety, Siemens assumes that as soon as there is an update that eliminates the problem, it will take corrective action.
  • Reason
    Siemens healthcare has recently detected that the combined use of phs1600 (material number 10643655) with perfusion scan mode "adaptive 4d spiral" may occasionally abort scanning on somaton definition as.
  • Action
    There is only one equipment commercialized in Brazil. Siemens forwarded a letter to the customer alerting the user that he should be aware of the increased risk of aborting a scan by using perfusion scan mode in combination with the PHS1600 table, especially when applying contrast medium. (Code CT045 / 15 / S)

Device

SOMATOM DEFINITION AS - Model 128-SLICES; 20-SLICES; 40-SLICES; 64-SLICES - Registration Number: ...

Manufacturer

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