Events

Device Recall Siemens RAPIDPoint 500 system 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
    71840
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2479-2015
  • 사례 시작날짜
    2015-07-28
  • 사례 출판 날짜
    2015-08-28
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-02-17
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139198
  • 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
    Acid, lactic, enzymatic method - Product Code KHP
  • 원인
    When both ports (serial and ethernet) are configured to transmit data, the data stream from one port could potentially affect the data stream from the other port causing the data management system to include either: duplicate data, missing data, or data from a different patient.
  • 조치
    Siemens Healthcare issued Urgent Field Safety Notice sent by e-mail to all affected Siemens Healthcare Diagnostics Regional offices on July 28, 2015, both in the United States and outside of the United States, for communication with affected customers. This notice informs customers of the issue with the RAPIDPoint 500 dual port LIS transmission feature. Users are informed to: If the system is currently set up with dual LIS transmission enabled, one of the ports (either Serial or Ethernet) needs to be disabled. Instruction provided with the notification. Customer to complete Field Effectiveness Check Form to confirm receipt of the notice. The resolution of this issue will be implemented in the next software release for the RAPIDPoint 500 system. If you have any questions, contact Siemens Customer Care Center or your local Siemens technical support representative. Please fax this completed Customer Care form to (312) 275-7795.

Device

Device Recall Siemens RAPIDPoint 500 system
  • 모델명 / 제조번호(시리얼번호)
    Units shipped between the dates Oct 2011 - June 2015 and within the serial range of 30003-37040 not inclusive.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (nationwide) Distribution and to the countries of : Albania, Algeria, Armenia, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia Herzeg, Brazil, Bulgaria,Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany,Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Italy, Japan, Kenya, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Mexico, Netherlands. New Zealand, Norway, P.R. China, Peru, Poland, Portugal, Qatar, Republic Korea, Romania, Russian Fed, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tunisia, Turkey, U.A.E., United Kingdom and Vietnam.
  • 제품 설명
    RAPIDPoint 500 Blood Gas Analyzer, || Siemens Material Numbers (SMN):10492730, 10696855, 10696857, 10697306 || This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary || whole blood samples.
  • Manufacturer
    Siemens Healthcare Diagnostics Inc

Manufacturer

Siemens Healthcare Diagnostics Inc
  • 제조사 주소
    Siemens Healthcare Diagnostics Inc, 2 Edgewater Dr, Norwood MA 02062-4637
  • 제조사 모회사 (2017)
    Siemens Ag
  • Source
    USFDA