Events

PET/CT Software Versions MSV 1.0 and 1.1 used in the following PET (Positron Emission Tomography) and X-Ray Computed Tomography (CT) systems: || ¿ Siemens Models: Biograph PET/CT || ¿ CTI Models: Reveal PET/CT 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
    30802
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0547-05
  • 사례 시작날짜
    2004-05-27
  • 사례 출판 날짜
    2005-02-16
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2008-10-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36628
  • 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
    Misalignment of ct and pet scans from performing additional ct scans may produce an incorrect fused data set. in performing additional ct scans, the original pet and ct scans may become misaligned and produce an incorrect fused data set.
  • 조치
    Written notification was sent via letter on May 27, 2004 to the end users to alert the consignees of the problem. The corrective software was mailed on December 17, 2004.

Device

PET/CT Software Versions MSV 1.0 and 1.1 used in the following PET (Positron Emission Tomography)...
  • 모델명 / 제조번호(시리얼번호)
    0054081001, 0054081002, 0054081003, 0054081004, 0054081006, 0054081007, 0054081008, 0054081009, 0054081010, 0054081011, 0054081012, 0054081013, 0054081014, 0054081015, 0054081016, 0054081017, 0054081018, 0054081020, 0054081021, 0054081022, 0054081023, 0054081024, 0054081025, 0067331002, 0067331003, 0067331004, 0067331005, 0067331006, 0067331007, 0067331008, 0067331009, 0067331010, 0067331011, 0067331012, 0067331013, 0067331014, 0067331015, 0067331016, 0067331017, 0067331018, 0067331019, 0067331020, 0067331021, 0067331022, 0067331023, 0067331024, 0067331025, 0067331026, 0067331027, 0067331029, 0067331030, 0067331031, 0067331032, 0067331033, 0067331034, 0067331035, 0067331036, 0067331037, 0067331038, 0067331039, 0067331040, 0067331041, 0067331042, 0067331043, 0067331044, 0067331045, 0067331046, 0067331047, 0067331048, 0067331049, 0067331050, 0067331051, 096-001002, 096-001004, 096-001005, 096-001006, 096-001007,  096-001008, 096-001009, 096-001011, 096-001012, 096-001013, 096-001014, 096-001015,  096-001016, 096-001017, 096-011002, 096-011003, 096-011005, 096-011006, 096-011007,  096-011008, 096-011009, 096-011010, 096-011011, 096-011012, 096-011013, 096-011014,  096-011015, 096-011016, 096-011017, 096-011018, 096-011019, 096-011020, 214-001002,  214-001003, 214-001004, 214-001005, 214-001006, 214-001007, 214-001008, 214-001016,  214-01001A, 214-011001, 214-011002, 214-011003, 214-011004, 214-011005, 214-011006,  214-011007, 214-011008, 214-011009, 214-011010, 214-011011, 214-011012, 214-011013,  214-011014, 214-011015, 214-011017, 214-011018, 214-011019, 214-011020, 214-011021,  214-011022, 214-011023, 214-011024, 214-011025, 214-011026, 214-011027, 214-011028,  214-011029, 214-011030, 214-011031, 214-011032, 214-011033, 214-011034, 214-011035,  214-011036, 214-011037, 214-011038, 214-011039, 214-011040, 214-011041, 214-011042,  216-001001, 216-001006, 216-001009, 216-001011, 216-001013, 216-001014, 216-001015,  216-001016, 216-001017, 216-001018, 216-001019, 216-001020, 216-001021, 216-001022,  216-001023, 216-001024, 216-001026, 216-001027, 0064871002, 0064871003, 0064871004, 0064871005, 0064871006, 0064871007, 0064871008, 0064871009, 0064871010, 0064871011, 0064871012, 0064871013, 0064871014, 0064871015, 0064871016, 0064871017, 0064871018, 0064871019, 0064871020, 0069391014, 0071301002, 0071301003, 0071301004, 0071301005, 0071301006, 0071301007, 0071301008, 0071301009, 0071301010, 0067331011, 0071301012, 0071301013, 0071301015, 0071301016, 0071301017, 0071301018, 0071301019, 0071301020, 0071301021, 0071301022, 0071301024
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide, Germany, Spain, Italy, Korea and Canada
  • 제품 설명
    PET/CT Software Versions MSV 1.0 and 1.1 used in the following PET (Positron Emission Tomography) and X-Ray Computed Tomography (CT) systems: || ¿ Siemens Models: Biograph PET/CT || ¿ CTI Models: Reveal PET/CT
  • Manufacturer
    CTI PET Systems Inc

Manufacturer

CTI PET Systems Inc
  • 제조사 주소
    CTI PET Systems Inc, 810 Innovation Dr, Knoxville TN 37932-2562
  • Source
    USFDA