Events

SIEMENS Luminos Agile Max 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
    71115
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1669-2015
  • 사례 시작날짜
    2015-04-13
  • 사례 출판 날짜
    2015-05-23
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-03-20
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137252
  • 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, x-ray, fluoroscopic, image-intensified - Product Code JAA
  • 원인
    Study and all acquired images deleted when using systems with software version ve10e. acquisitions have to be repeated. connection with portable detectors (max wi-d, max mini) is sporadic in image recovery. pressing undo button on the rad subtask card or previous series button on the image subtask card during image readout. sporadically, during an automatic or a manual ris update.
  • 조치
    A safety advisory notice, dated April 13, 2015, was sent to end users with affected devices to alert them about the issue and associated risks,and to provide instructions for avoiding potential risk. A new software version will be released to permanently resolve the issue.

Device

SIEMENS Luminos Agile Max
  • 모델명 / 제조번호(시리얼번호)
    Model Number of device   10762472 with serial numbers: 61034 61052 61045 61013 61054 61056 61021 61050 61053 61032 61015 61046 61028 61040 61011 61029 61048 61060 61042 61035 61014 61025 61043 61036 61038 61022 61037 61049 61044 61062 61030 61018 61027 61061 61033 61039 61047 61031 61041 61055 61019 61057 61059 61017 61051
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution.
  • 제품 설명
    SIEMENS Luminos Agile Max; a universal imaging system for radiographic and fluoroscopic studies. Using either film cassettes or a digital mobile flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. Luminos Agile is applicable to emergency treatment on an outpatient basis, as well as for bedside examinations.
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • 제조사 주소
    Siemens Medical Solutions USA, Inc, 51 Valley Stream Pkwy, Malvern PA 19355-1406
  • 제조사 모회사 (2017)
    Siemens Ag
  • Source
    USFDA