Events

mobile system PET scanner 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 CTI PET Systems 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
    31770
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0819-05
  • 사례 시작날짜
    2005-04-05
  • 사례 출판 날짜
    2005-05-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2009-09-11
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38469
  • 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
    System, Tomography, Computed, Emission - Product Code KPS
  • 원인
    Failure to properly secure the mobile bed supports during transit could cause the support screws on the patient handling system to become loose and possibly break due to increased vibration during transit.
  • 조치
    Written notification via certified US Mail was sent out beginning 04/05/2005 to distributors and end users (with whom CTI had a service contract) to advise them of the problem.

Device

mobile system PET scanner
  • 모델명 / 제조번호(시리얼번호)
    Model Number: 3600079-00 Serial numbers: 0001013, 0001014  Model Number: 3600088-00 Serial numbers: 0001010, 0001016, 0001017, 0001019, 0001021, 0001023, 0001027, 0001029, 0001030, 0001031, 0001038, 0001041, 0001048, 0001051, 0001053, 0001054  Model Number: 3600097-00 Serial numbers: 0101004, 0101019, 0101025, 0101033, 0201041, 0201049, 0201053, 0201063  Model Number: 3600211-00 Serial numbers: 0101007, 0101016, 0101018, 0201023, 0201048, 0201050, 0201058, 0201064, 0201072, 0301082,   Marketed under Siemens Model Number: 3600211-00 0101002, 0101004, 0101015, 0101014, 0101020, 0101021, 0201029, 0201028, 0201035, 0201062, 0201059, 0201063, 0201070, 0301110  Model Number: 3600079-00 Serial numbers: 0001010, 0001011, 0001018  Model Number: 3600085-00 Serial numbers: 0001001, 0001002  Model Number: 3600088-00 Serial numbers: 0001003, 0001006, 0001020, 0001035, 0001036, 0001043, 0001045, 0001044, 0001056, 0001062  Model Number: 3600097-00 Serial numbers: 0101016, 0101018, 0101030, 0201036, 0201040, 0201060  Model Number: 3600211-00 Serial numbers: 0201033, 0201034, 0201067, 0301108  Model Number: 3600099-00 Serial numbers: 0301024  Model Number: 3600088-00 Serial numbers: 001058  Model Number: 3600097-00 Serial numbers: 0101034, 0201038, 0201061
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide, Canada, the Netherlands, Ireland & Denmark
  • 제품 설명
    ECAT PET Scanners (mobile systems), distributed by Siemens Medical Solutions || ECAT PET Scanners (mobile systems), and Reveal XL (mobile systems), distributed by CTI Molecular Imagining, Inc. || Sceptre and Sceptre XL (mobile systems) distributed by Hitachi Medical Systems America
  • Manufacturer
    CTI PET Systems Inc

Manufacturer

CTI PET Systems Inc
  • 제조사 주소
    CTI PET Systems Inc, 810 Innovation Drive, Knoxville TN 37932-2571
  • Source
    USFDA