Events

Device Recall System 83 Plus 2 Endoscope/Washer/Disinfector 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Custom Ultrasonics, 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
    74311
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2130-2016
  • 사례 시작날짜
    2016-05-06
  • 사례 출판 날짜
    2016-07-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-04-18
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147130
  • 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
    Washer, cleaner, automated, endoscope - Product Code NVE
  • 원인
    To warn customers that custom ultrasonics, inc. system 83 plus aers should not be used for cleaning and/or high-level disinfection of duodenoscopes until further notice.
  • 조치
    Custom Ultrasonics, Inc. sent an Urgent Medical Device Recall letter dated May 6, 2016, to all affected customers. The letter advised customers not to use the System 83 Plus AERs for cleaning and/or high-level disinfection of duodenoscopes until further notice. In addition, they sent a warning label for customers to affix in a prominent location on the System 83 Plus AER's on or before June 3, 2016 stating the following: "This device is not indicated for reprocessing of duodenoscopes. Do not reprocess any duodenoscopes in this device until further notice. For alternative reprocessing options, please contact the duodenoscope manufacturer." For questions regarding this recall call 215-364-1477.

Device

Device Recall System 83 Plus 2 Endoscope/Washer/Disinfector
  • 모델명 / 제조번호(시리얼번호)
    All serial numbers
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution to IN, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD., ME, MI, MN, MO,MS, MT, NC, NE, NH, NJ, NM, NV, NY OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT,WA, WI, WV, and WY.
  • 제품 설명
    The System 83 Plus, Endoscope Washer/Disinfector || Designed for the simultaneous reprocessing of up to two flexible submersible endoscopes that are used in the gastrointestinal and/or pulmonary tracts.
  • Manufacturer
    Custom Ultrasonics, Inc.

Manufacturer

Custom Ultrasonics, Inc.
  • 제조사 주소
    Custom Ultrasonics, Inc., 144 Railroad Dr, Ivyland PA 18974-1449
  • 제조사 모회사 (2017)
    Custom Ultrasonics Inc
  • Source
    USFDA