Events

Safety Alert for Commercial Name: PETROLEUM TOMOGRAPHY EQUIPMENT BY PETROLEUM (PET) / COMPUTERIZED TOMOGRAPHY (CT) BIOGRAPH; Model: Biograph mCT Flow; Biograph mCT Flow Edge; Biograph mCT-S; Biograph mCT-X; Biograph 6 TruePoint; Biograph 40 TruePoint; Biograph 64 TruePoint; Biograph 16; Biograph 16 TruePoint; Anvisa record: 10234230170; risk class III; lots / series under risk: 1042; 1066; 1070; 1095; 45567; 45631; 45654; 45663; 11048; 11033; 1010; 31081; 11045; 11046; 11072; 11036; 72407; 72453; 72455; 72460; 72461; 72466; 72475; 72477; 72501; 72413; 72446; 21073; 21077; 21128; 21131; 21138; 11008.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Siemens Ltda.; Siemens Medical Solutions USA, Inc.; 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
    1901
  • Date
    2016-05-25
  • 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
    Recommendations for users and patients: To correct the variation in mu values, Siemens recommends that you perform the cross-calibration procedure of the scanner. In addition to cross-calibration of the PET scanner relative to the dose calibrator, this procedure will also take into account the different mu values ​​of a solid third-party Germanium-68 quality phantom or liquid to ensure the most accurate quantification in corrected attenuation PET images .
  • Reason
    Siemens healthcare informs that using a different phantom from siemens solid germanium-68 phantom can affect the calibration factor values ​​generated during the pet quality control procedure. depending on the type of uniform phantom used to perform the pet quality control, the pet calibration factor may be biased due to the fact that the system uses a specific mu value of 0.1 cm -1, which is based on the germanium-68 phantom from siemens. the system will use this default mu value regardless of the actual mu value of the phantom used for the pet quality control; this may cause a variation in the quantification of pet images with corrected attenuation.
  • Action
    Action code MI503 / 16 / S. Letter to affected customers

Device

Commercial Name: PETROLEUM TOMOGRAPHY EQUIPMENT BY PETROLEUM (PET) / COMPUTERIZED TOMOGRAPHY (CT)...

Manufacturer

Siemens Ltda.; Siemens Medical Solutions USA, Inc.; Siemens Ltda
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    ANVSANVISA