Events

Device Recall ECAT EXACT HR 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
    45154
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0273-2008
  • 사례 시작날짜
    2007-07-23
  • 사례 출판 날짜
    2007-11-29
  • 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=64984
  • 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
    Tomography Computed Emission System - Product Code KPS
  • 원인
    Incorrect data results - ecat system's software versions 7.2.2 and 7.4 may calculate the decay correction for emission data incorrectly while performing whole-body studies with all transmissions followed by all emissions.
  • 조치
    Siemans sent an Urgent Device Correction letter, dated June 15, 2007, to all affected consignees informing the user of the problem and requesting that they discontinue the practice of running all transmissions followed by all emissions until a corrective software patch is installed. The corrective software patch is expected to be installed by October 2007.

Device

Device Recall ECAT EXACT HR
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: 070-001012, 070-001021, 070-001022, 070-001024, 080-001014, 1001, 1005, 1009, 101007, 1011, 1026, 3600063-00-0001002, 3600063-00-0001004, 3600063-00-0001005, 3600063-00-0001007, 3600063-00-0001008, 3600070-00-0001001, 3600070-00-0001003, 3600070-00-0001006, 3600070-00-0001007, 3600070-00-0001008, 3600070-00-0001013, 3600070-00-0001015, 3600070-00-0001016, 3600070-00-0001017, 3600070-00-0001018, 3600070-00-0001019, 3600070-00-0001023, 3600070-01-0001001, 3600070-01-001002, 3600070-01-001004, 3600070-01-001006, 3600070-01-001008, 3600070-01-001011, 3600070-01-001017, 3600070-01-001020, 3600070-01-001027, 3600070-01-001037, 3600070-01-001043, 3600070-01-001063, 3600076-00-0001001, 3600076-00-0001002, 3600076-00-0001003, 3600080-00-0001002, 3600080-00-0001003, 3600080-00-0001004, 3600080-00-0001006, 3600080-00-0001007, 3600080-00-0001008, 3600080-00-0001009, 3600080-00-0001010, 3600080-00-0001011, 3600080-00-0001012, 3600080-00-0001013, 3600080-00-0001016, 3600086-00-0001002, 3600086-00-0001003, 3600086-00-0001004, 3600089-00-0001002, 3600089-00-0001003, 3600089-00-0001004, 3600089-00-0001005, 3600089-00-0001006, 3600089-00-0001007, 3600089-00-0001008, 3600089-00-0001010, 3600089-00-0001011, 3600089-00-0001012, 3600089-00-0001013, 3600089-00-0001014, 3600089-00-0001017, 3600089-00-0001018, 3600089-00-0001019, 3600089-00-0001021, 3600089-00-0001022, 3600098-00-0101002, 3600098-00-0101003, 3600098-00-0101004, 3600098-00-0101005, 3600098-00-0101006, 3600098-00-0101008, 3600098-00-0101009, 3600098-00-0101010, 3600098-00-0101012, 3600098-00-0101013, 3600098-00-0101015, 3600098-00-0101016, 3600098-00-0101017, 3600098-00-0101018, 3600098-00-0101019, 3600098-00-0101020, 3600098-00-0101021, 3600098-00-0101022, 3600098-00-0101023, 3600098-00-0101024, 3600098-00-0101025, 3600098-00-0101026, 3600098-00-0101027, 3600098-00-0101030, 3600098-00-0201028, 3600098-00-0201029, 3600098-00-0201031, 3600098-00-0201032, 3600098-00-0201033, 3600098-00-0201034, 3600098-00-0201035, 3600098-00-0201036, 3600098-00-0201037, 3600098-00-0201038, 3600098-00-0201039, 3600098-00-0301040, 3600098-00-0401044, 3800098-00-0201034, 401045, 9501006, 9601002, 9801029
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA and Countries of Argentina, Austria, Belgium, Brazil, Canada, Switzerland, Chile, China, Czech Republic, Germany, Denmark, Spain, Finland, France, Great Britain, Italy, Japan, South Korea, Netherlands, Norway, Saudi Arabia, Sweden, Slovak Republic, Turkey, and Taiwan.
  • 제품 설명
    Siemens ECAT EXACT HR+, Catalog No. 3548083, PET/CT Scanner, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534
  • Manufacturer
    Siemens Medical Solutions USA Inc

Manufacturer

Siemens Medical Solutions USA Inc
  • 제조사 주소
    Siemens Medical Solutions USA Inc, 810 Innovation Dr, Knoxville TN 37932-2562
  • Source
    USFDA