Events

Device Recall System 98XT/98 IntraAortic Balloon Pump 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Datascope Corporation 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
    55649
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1813-2010
  • 사례 시작날짜
    2010-05-10
  • 사례 출판 날짜
    2010-06-21
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-10-27
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91489
  • 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
    System, balloon, intra-aortic and control - Product Code DSP
  • 원인
    Certain maquet/datascope intra-aortic balloon pumps (iabp) have the potential to experience display related issues. although the iabp continues to deliver therapy to the patient, display related issues may cause the user to be unable to view the iabp on the information screen.
  • 조치
    Medical Device Recall Letters were sent to Hospital Administrators beginning May 10, 2010 by overnight mail. Customers with questions are directed to contact your local Sales/Service Representative or the company representative at 973-244-6314.

Device

Device Recall System 98XT/98 IntraAortic Balloon Pump
  • 모델명 / 제조번호(시리얼번호)
    Product number 0998-00-0446-XX and 0998-00-0479-XX. SN# S8119767B8 S8119768B8 S8119769B8 S8119771B8 S8119773B8 S8119774B8 S8119775B8 S8119778B8 S8119780B8 S8119781B8 S8119782B8 S8119764B8 S8119766B8 S8119770B8 S8119772B8 S8119776B8 S8119779B8
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Class 2 - Worldwide distribution -- US and Distribution to Australia, Belarus, Belgium, Canada, Egypt, England, Germany, Hong Kong, India, Iran, Israel, Japan, Kuwait, Latvia, Lebanon, Serbia, Singapore, Spain, Switzerland, Turkey, Venezuela.
  • 제품 설명
    System 98XT/98 Intra-Aortic Balloon Pump || This product was only distributed in India and Hong Kong/China.
  • Manufacturer
    Datascope Corporation

Manufacturer

Datascope Corporation
  • 제조사 주소
    Datascope Corporation, 15 Law Dr, Fairfield NJ 07004-0011
  • 제조사 모회사 (2017)
    Getinge AB
  • Source
    USFDA