Events

Device Recall Siemens ADVIA 560 Hematology Systems 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Siemens Healthcare Diagnostics, 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
    73588
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1500-2016
  • 사례 시작날짜
    2016-03-10
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-06-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144542
  • 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
    Software anomaly; siemens identified that software version 1.4.2133 on the advia 560 hematology system does not trigger the following flags: the g or l morphology flags for immature granulocytes (ig) and atypical lymphocytes (atyp), respectively. the results from patient samples which have immature granulocytes or atypical lymphocytes will not generate the flags when they should. as defined in t.
  • 조치
    Siemens sent an Urgent Medical Device Correction Letter dated March 11, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. .Actions to be Taken by the Customer: To ensure that the patient sample amount for processing is met, follow the requirements for the amount of sample required in the ADVIA 560 Hematology System Operators Guide. Review all patient results for abnormal white blood cell results and process as defined by your lab criteria for abnormal samples and confirm using manual differentials as needed. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. Please review this letter with your Medical Director. Your Siemens Customer Service Engineer will contact you to schedule time for installation of the 1.4.2333 software when it is available. Please retain this letter with your laboratory records, and forward this letter to those who may have received this product. We apologize for the inconvenience this situation may cause. If you have any questions, please contact your Siemens Customer Care Center or your local Siemens technical support representative. For further questions, please call (312) 275-7795.

Device

Device Recall Siemens ADVIA 560 Hematology Systems
  • 모델명 / 제조번호(시리얼번호)
    All serial numbers of ADVIA 560 Hematology Systems.
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Distribution including Puerto Rico and to the states of : California, Illinois, Washington and Wisconsin., and to the countries of : Angola, Austria, Canada, Chile, Colombia, Czech Republic, France, Germany, India, Italy, Kenya, Netherlands, Norway, Portugal, Singapore, Slovenia, Spain, Turkey, Uganda and United Kingdom.
  • 제품 설명
    ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD || The ADVIA 560 Hematology System is a fully-automated, high-quality hematology system for in vitro diagnostic use in clinical laboratories
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • 제조사 주소
    Siemens Healthcare Diagnostics, Inc., 511 Benedict Ave, Tarrytown NY 10591-5005
  • 제조사 모회사 (2017)
    Siemens Ag
  • Source
    USFDA