Events

Device Recall PT100/PT Link Waterbath 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Dako North America 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
    53336
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0287-2013
  • 사례 시작날짜
    2008-05-01
  • 사례 출판 날짜
    2012-11-13
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-11-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85291
  • 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
    Bath, flotation, tissue - Product Code IDY
  • 원인
    Dako is recalling the pt link waterbath because of a possible electrical hazard. specifically, if the heater pad under the reagent tank becomes wet, it may present an electrical shock hazard when the lid is open.
  • 조치
    The firm, Dako, sent a "DAKO PT LINK ADVISORY NOTICE" dated May 1, 2008 to customers who purchased the PT Waterbath along with a customer acknowledgement document informing the users of the potential electrical hazard. The notice described the product, problem and actions to be taken. The customers were instructed to follow the attached Safety Instructions; place the enclosed warning labels directly on the instrument as shown in the attached instructions and adhere to the warning labels as described. Customers with questions were instructed to call Dako Products' Technical Support at (800) 424-0021.

Device

Device Recall PT100/PT Link Waterbath
  • 모델명 / 제조번호(시리얼번호)
    Catalog #: PT-Module
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution: USA including states of: AK, CA, CO, CT, DC, FL, GA, HI, IA, IL IN, KS, KY, MA, MD, MI, MN, MO, NE, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, and WA.
  • 제품 설명
    PT Link Waterbath, Model#PT100. || Lab Vision PT Module Plus provides an automated standarized alternative to labor intensive and time consuming dewaxing and epitote retrieval procedures.
  • Manufacturer
    Dako North America Inc.

Manufacturer

Dako North America Inc.
  • 제조사 주소
    Dako North America Inc., 6392 Via Real, Carpinteria CA 93013-2921
  • 제조사 모회사 (2017)
    Agilent Technologies, Inc.
  • Source
    USFDA