Events

Cryosurgical Freezer 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Cooper Surgical, 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
    53436
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0091-2010
  • 사례 출판 날짜
    2009-10-29
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-04-17
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85499
  • 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
    Unit, cryosurgical, accessories - Product Code GEH
  • 원인
    Co2 cryosystem thermal load may exceed the exhaust gas phase, resulting in ice formation in the exhaust valve. should this occur, the cryo tip may cool at a less than optimal rate, resulting in ice formation in the exhaust valve.
  • 조치
    Cooper Surgical notified customers by letter titled "Notice of Recall - Urgent" dated September 29, 2009 advising them of the problem and requesting return of the device. International accounts were notified by letter Beginning October 1, 2009. For further information, contact Cooper Surgical by fax at 1-203-799-2002 or phone at 1-203-799-2000.

Device

Cryosurgical Freezer
  • 모델명 / 제조번호(시리얼번호)
    Serial Number Prefixes of Affected Product: A, AN,DN, EN, FA, JN, LN, 03, 04, 07, 08, 09,11,12
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- United States, Canada, Australia, Belgium, England, France, Germany, Greece, Hungary, Iceland, Italy, Ireland, Latvia, Lithuania, Netherlands, Portugal, Spain, Solvenia, Sweden, Hong Kong, Republic of China, Taiwan, Angola, Cameroon, Congo, Croatia, Egypt, Ghana, Guam, Guineae Bissau, Indonesia, Kenya, Kuwait, Lebanon, Madagascar, Mali, Mauritania, Mozambique, New Zealand, Niger, Pakistan,Qatar, Russia, Sao Tome, Saudi Arabia, Senegal, Serbia, Singapore, South Africa, St Vincents & Grenadines, Oman, Thailand, Turkey, UAE and Zimbabwe.
  • 제품 설명
    Wallach LL100 Cryosurgical Freezer CO2 Unpinned Yoke System CO2 || Model: 900000.
  • Manufacturer
    Cooper Surgical, Inc.

Manufacturer

Cooper Surgical, Inc.
  • 제조사 주소
    Cooper Surgical, Inc., 95 Corporate Dr, Trumbull CT 06611
  • 제조사 모회사 (2017)
    The Cooper Companies, Inc.
  • Source
    USFDA