Events

Recall Or Safety Alert for "Biograph True Point" systems with syngo 6.7.x PET software, "Biograph mCT", "Biograph mCT Flow".

According to Agencia Española de Medicamentos y Productos Sanitarios (Via FOI), this recall or safety alert involved a device in Spain that was produced by Siemens Medical Solutions, Inc.

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
    Recall / Safety Alert
  • Date
    2016-06-13
  • Event Country
    Spain
  • Event Source
    AEMPSVFOI
  • Notes / Alerts
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 recall data from the U.S. and Spain.
  • Extra notes in the data
  • Action
    The use of phantoms other than solid germanium 68 supplied by Siemens may affect the calibration values ​​that are generated during the PET quality control procedure in the "Biograph True Point" systems with the syngo 6.7.x PET software, "Biograph mCT", "Biograph mCT Flow", manufactured by Siemens Medical Solutions, Inc, USA.

Device

"Biograph True Point" systems with syngo 6.7.x PET software, "Biograph mCT", "Biograph mCT Flow".

Manufacturer

Siemens Medical Solutions, Inc
  • Manufacturer Parent Company (2017)
    Siemens AG
  • Source
    AEMPSVFOI