Events

Device Recall Symbia T Series SPECTCT System with a Pinhole Collimator 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Siemens Medical Solutions USA, Inc. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    37231
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0549-2007
  • 사례 시작날짜
    2007-01-30
  • 사례 출판 날짜
    2007-02-23
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2007-11-30
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50371
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Single-Photon Emission Computed Tomography - Product Code JAK
  • 원인
    Symbia systems, running on e.Soft version 5.5 or earlier, could allow a fully-extended patient pallet to come into contact with the pinhole collimator, resulting in system damage.
  • 조치
    Siemens sent Customer Safety Advisory Notice/Urgent Field Correction Recall letters dated 1/30/07 to all users of Symbia systems with a pinhole collimator and e.soft software versions 5.5 or earlier. The accounts were informed of the potential for a fully-extended patient pallet to come into contact with the pinhole collimator, resulting in system damage. The customers were advised that a Siemens Customer Service Representative would be sent to their site to upgrade their system software to version syngeo MI Applications 2006A within 30 days. The upgrade will be done free of charge.

Device

Device Recall Symbia T Series SPECTCT System with a Pinhole Collimator
  • 모델명 / 제조번호(시리얼번호)
    All systems with pinhole collimators and e.soft software versions 5.5 or earlier part number 08717733, serial numbers 01015, 01032, 01037, 01045, 01061, 01065, 01068, 01072, 01074, 01076, 01077
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution --- including USA states of Alabama, California, Georgia, Indiana, Kentucky, Michigan, Ohio, Pennsylvania, Texas, Virginia and countries of Australia, Bolivia, Canada, China, France, Germany, Hong Kong and Spain.
  • 제품 설명
    Symbia T Series SPECT-CT (Single-Photon Emission Computed Tomography and Computed Tomography) System with a Pinhole Collimator; Siemens Medical Solutions USA, Inc., Molecular Imaging, 2501 N. Barrington Road, Hoffman Estates, IL 60195-5203 USA; part number 08717733
  • Manufacturer
    Siemens Medical Solutions USA, Inc.

Manufacturer

Siemens Medical Solutions USA, Inc.
  • 제조사 주소
    Siemens Medical Solutions USA, Inc., 2501 Barrington Rd, Hoffman Estates IL 60195-2061
  • 제조사 모회사 (2017)
    Siemens Ag
  • Source
    USFDA