Events

Device Recall Sysmex XN Series Automated Hematology Analyzers 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Sysmex America 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
    76828
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2034-2017
  • 사례 시작날짜
    2017-03-23
  • 사례 출판 날짜
    2017-04-14
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154358
  • 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
    Counter, differential cell - Product Code GKZ
  • 원인
    Reported customer complaints of automated hematology analyzers catching fire due to misalignment of an internal protective sheet that shields electronic components from salty reagents. build-up of salt deposits on unprotected electronic components may combust due to heat generated by electronics when instrument cycles. completed capa identified the root cause as supplier providing defective component (sensor ready valve) and the misalignment of the electronic protective shield during manufacturing of the device.
  • 조치
    Sysmex sent an Field Correction letter dated April 2017. Product will not be returned, but corrected at the customer site. The correction requires a service visit that will be documented in the Sysmex service Customer Relationship Management (CRM) software. The service report is accepted by the customer at the time of service. Completion of the service records will be tracked by reports generated from the Service CRM. For further Technical Assistance or questions please call (1 888) 879-7639.

Device

Device Recall Sysmex XN Series Automated Hematology Analyzers
  • 모델명 / 제조번호(시리얼번호)
    **Model: XN-10, Product Number: AP795756, Serial Numbers: 11001  29656, 29668-29786, 29788-29798, 29800-29801, 29803, 29804, 29807, 29812, 29816-29867  **Model: XN-11, Product Number: CS297931, Serial Numbers: A1001-A1124, A1127, A1130, A1135-A1140, A1142-A1144, A1146-A1149, A1151, A1153-A1159, A1161, A1163, A1171
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide, Canada
  • 제품 설명
    Sysmex, Automated Hematology Analyzer XN Series, Sysmex Corporation, 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073 Japan
  • Manufacturer
    Sysmex America Inc

Manufacturer

Sysmex America Inc
  • 제조사 주소
    Sysmex America Inc, 577 Aptakisic Rd, Lincolnshire IL 60069-4325
  • 제조사 모회사 (2017)
    Sysmex Corp.
  • Source
    USFDA