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Biograph TruePoint systems running PETsyngo 6.7.x software 에 대한 현장 안전성 서한

Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI)에 따르면, 해당 현장 안전성 서한 는 Slovenia 에서 Siemens Medical Solutions USA, Inc. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Field Safety Notice
  • 사례 국가
    Slovenia
  • 사례 출처
    AMPMDRS
  • 비고 / 경고
    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.
  • 데이터 추가 비고
  • 원인
    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.