Events

Device Recall syngo Dynamics Version 9.5 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
    62581
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2219-2012
  • 사례 시작날짜
    2012-07-13
  • 사례 출판 날짜
    2012-08-17
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-07-15
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111087
  • 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, image processing, radiological - Product Code LLZ
  • 원인
    If multiple uncompressed images/clips are sent to the syngo dynamics server, around the same time, it is possible for an image from a patient to be placed in another patient's study.
  • 조치
    On 07/13/2012, Siemens issued a "Customer Safety Advisory Notice" to affected consignees according to Update Instruction SY062/121S. The notice informs the customers of the potential issue with the identified affected product and provides details regarding the resolution. A software update to relieve the symptom of the issue will be distributed and installed by a Siemens Service Engineer on all affected systems under Update Instruction SY063/121S. A software update to correct this issue will be distributed and installed by a Siemens Service Engineer on all affected systems under Update Instruction SY064/121S.

Device

Device Recall syngo Dynamics Version 9.5
  • 모델명 / 제조번호(시리얼번호)
    10091862 and 10091863
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution -- MA, GA, MO, IA, CA, PA, OR, CO, NY, NJ, WA, UT, OH, WI, MI, KY, and NC.
  • 제품 설명
    syngo Dynamics Version 9.5
  • Manufacturer
    Siemens Medical Solutions, USA, Inc

Manufacturer

Siemens Medical Solutions, USA, Inc
  • 제조사 주소
    Siemens Medical Solutions, USA, Inc, 400 Morgan Rd, Ann Arbor MI 48108
  • Source
    USFDA