Events

Terumo APS 1 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Terumo Cardiovascular Systems Corp 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
    36396
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0336-2007
  • 사례 시작날짜
    2004-10-12
  • 사례 출판 날짜
    2006-12-30
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2007-02-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48589
  • 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
    Perfusion System - Product Code DTQ
  • 원인
    Device module(s) may fail to properly initialize during start up, thus resulting in that single module being inoperable and a red 'x' being displayed on the monitor screen.
  • 조치
    U.S. consignees were sent an addendum to the operators manual on October 12, 2004 instructing them to cycle power to the unit to clear the error. International distributors were requested to provide this information to their customers on 12/15/04, but Terumo has not yet received confirmation that this was completed.

Device

Terumo APS 1
  • 모델명 / 제조번호(시리얼번호)
    Serial numbers 00010 through 00016, 00019, 00024 through 00027, 00030 through 00033, 00035, 00036, 00038 through 00040, 00042 through 00046, 00048 through 00050, 00052 through 00054, 00056 through 00059, 00061 through 00063, 00065, 00066, 00068, 00069, 00071 through 00073, 00075 through 00078, 00082, 00084, 00085, 00087, 00088, 00091, 00094, 00095, 00098 through 00103, 00105 through 00107, 00109 through 00111, 00113 through 00115, 00122, 00126 through 00129, 00133 through 00135, 00139, 00140, 00144, 00145, 00147, 00148, 00151, 00152, 00154 through 00157, 00163, 00167, 00168 through 00174, 00176 through 00182, 00184 through 00196, 00200, 00202 through 00206, 00210, 00211, 00213, 00214, 00216 through 00224, 00228 through 00231, 00237 through 00241, 00245 through 00250, 00300 through 00327 and 00330.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA and countries Australia, Belgium, Canada, China, Dominican Republic, Egypt, Germany, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Republic of China, Singapore, South Africa, South Korea, Thailand and United Arab Emirates.
  • 제품 설명
    Terumo Advanced Perfusion System 1 Electronic Oxygen Blender/analyzer; Catalog number 801188.
  • Manufacturer
    Terumo Cardiovascular Systems Corp

Manufacturer

Terumo Cardiovascular Systems Corp
  • 제조사 주소
    Terumo Cardiovascular Systems Corp, 6200 Jackson Rd, Ann Arbor MI 48103-9586
  • Source
    USFDA