Events

Field Safety Notices about Biograph TruePoint systems running PETsyngo 6.7.x software

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Siemens Medical Solutions USA, Inc. .

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Extra notes in the data
  • Reason
    Depending on the type of uniform phantom utilized to perform the pet quality control, the pet calibration factor may be biased due to the system using a specific mu-value of 0.1 cm-1 which is based on the siemens solid germanium-68 phantom. the system will use this default mu-value, regardless of the actual mu-value of the phantom utilized for pet quality control; this may cause a variation in the quantification of the attenuation corrected pet images in order to correct for the variation in mu-values, we recommend that you perform the scanner cross calibration procedure after the 6.7.X software upgrade as well as every time the pet quality phantom is replaced. in addition to cross calibrating the pet scanner to the dose calibrator, this procedure will also account for the mu-value of a liquid or third-party solid germanium-68 quality phantom to ensure more accurate quantification in the pet attenuation corrected images. for complete instructions on the cross calibration procedure, please see your siemens biograph operator’s manual. .

Device

Biograph TruePoint systems running PETsyngo 6.7.x software

Manufacturer

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