Events

Device Recall Hettich Centrifuge Rotor 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Hettich Instruments Management I 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
    53941
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-0612-2010
  • 사례 시작날짜
    2009-11-21
  • 사례 출판 날짜
    2010-01-21
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-10-25
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86894
  • 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
    Hematocrit Centrifuge - Product Code GKG
  • 원인
    Centrifuge rotor failure: may crack, break, and explode outside the centrifuge.
  • 조치
    Hettich Instruments notified Distributors by email on 11/21/09, to the Request For Urgent Action notifications, dated 11/23/2009. There is a description of how to identify a recalled rotor as well as a description of the replacement metal rotor that is to be used in place of the list of centrifuges affected by this recall. Customers are to cease using the setup described and contact their distributor or the firm. The firm will replace the plastic housing with a metal housing. Questions should be directed to 978-232-3957.

Device

Device Recall Hettich Centrifuge Rotor
  • 모델명 / 제조번호(시리얼번호)
    Units with plastic motor housing. TYP #2070 and TYP 2070-01
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA, including states of CT and IN, and country of Canada.
  • 제품 설명
    Mikro 12-24 Centrifuge with 2050 Rotor || TYP #2070 and TYP 2070-01. || Used for the purpose of determining the hematocrit count of a patient sample by way of applying centrifugal force in a manner that separates red blood cells and allows the proportion of red cell mass to plasma to be measured.
  • Manufacturer
    Hettich Instruments Management I

Manufacturer

Hettich Instruments Management I
  • 제조사 주소
    Hettich Instruments Management I, 100 Cummings Ctr Ste 130g, Beverly MA 01915-6127
  • Source
    USFDA