Events

Device Recall Siemens Healthcare Diagnostics 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
    68437
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2079-2014
  • 사례 시작날짜
    2014-05-23
  • 사례 출판 날짜
    2014-07-18
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-06-10
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127701
  • 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
    Rapidpoint 500 measurement cartridges may have an error code one or more electrolyte parameters (e.G., na+, ca++, k+, cl-).
  • 조치
    Siemens Healthcare Diagnostics issued an Urgent Field Safety Notice by e-mail to all affected Siemens Healthcare Diagnostics Regional offices on May 27, 2014 both in the United States and elsewhere for communication with affected customers. This notice informs customers of the issue with the RAPIDPoint 500 Measurement cartridges. Questions contact: Siemens Customer Care Center or your local Siemens technical support representative at 877-229-3711. What steps can be taken to mitigate the issue: " Install a new RAPIDPoint 500 Measurement Cartridge. or " Install a 405 Measurement Cartridge - The RAPIDPoint 405 cartridge is available in four sizes: Since the Lactate parameter is not available on the RAPIDPoint 405 cartridge, however, you will need to arrange to get your lactate results from other instruments in your central laboratory. or " Use an alternative system to obtain your electrolyte values.

Device

Device Recall Siemens Healthcare Diagnostics
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: 2334500011 through 2412705915
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Foreign: U.A.E. Albania Austria Australia Bosnia Herzeg. Belgium Bulgaria Bahrain Brazil Canada Switzerland P.R. China Colombia Czech Republic Germany Denmark Algeria Estonia Egypt Spain Finland France United Kingdom Georgia Greece Hong Kong Croatia Hungary Indonesia Ireland Israel India Italy Japan Republic Korea Kuwait Lithuania Luxembourg Latvia Malaysia Mexico Netherlands Norway New Zealand Peru Poland Portugal Qatar Romania Serbia Russian Fed. Saudi Arabia Sweden Singapore Slovenia Turkey Taiwan
  • 제품 설명
    RAPIDPoint 500 Measurement Clinical Chemistry System || RAPIDPoint 500 Measurement Cartridge Lactate (750 Tests) || Part number: 10491449; || RAPIDPoint 500 Measurement Cartridge Lactate (400 Tests) || Part Number: 10491448 || RAPIDPoint 500 Measurement Cartridge Lactate (250 Tests) || Part Number: 10491447 || RAPIDPoint 500 Measurement Cartridge Lactate (100 Tests) || Part Number:10844813
  • Manufacturer
    Siemens Healthcare Diagnostics Inc

Manufacturer

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