Events

Device Recall Ultraview SL Capnography Module, Model 91517 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Spacelabs Medical Incorporated 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
    32815
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0517-06
  • 사례 시작날짜
    2005-07-20
  • 사례 출판 날짜
    2006-02-16
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2006-02-17
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=40875
  • 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
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase - Product Code CCK
  • 원인
    The transducer used to compensate for pressure changes was mounted backwards on the printed circuit board assembly. the module will not compensate for pressure changes and co2 readings will be inaccurate at higher altitudes.
  • 조치
    On 7/20/05 Spacelabs called the consignees that received the units to notify them of the hazard and also the schedule a service call to repair the affected capnography modules. The firm will confirm that all consignees have been updated with the appropriate PCBA and will audit the device recall records for completion.

Device

Device Recall Ultraview SL Capnography Module, Model 91517
  • 모델명 / 제조번호(시리얼번호)
    Model 91517 Lot BMP007559
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    8 units shipped to France, 1 unit to Brussels, Belgium, and 2 units to a medical center in WY.
  • 제품 설명
    Ultraview SL Capnography Module, Model 91517 || A mainstream and sidestream gas analyzer designed to measure the concentration of carbon dioxide in a gas mixture, to aid in determining the patient''s ventilatory, circulatory, and metabolic status.
  • Manufacturer
    Spacelabs Medical Incorporated

Manufacturer

Spacelabs Medical Incorporated
  • 제조사 주소
    Spacelabs Medical Incorporated, 5150 220th Ave Se, Issaquah WA 98029-6834
  • Source
    USFDA