Events

Device Recall ECATS E 850 Bariatric Bed 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 SCM True Air Technologies LLC 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
    67924
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1631-2014
  • 사례 시작날짜
    2014-03-18
  • 사례 출판 날짜
    2014-05-19
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-06-11
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126957
  • 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
    Bariatric bed - Product Code OSI
  • 원인
    The firm is recalling the products due to lack of design controls, lack of a device master record, and failure to approve specific vendors.
  • 조치
    SCM True Air Technologies LLC sent an Urgent Medical Device Recall letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to remove the affected product from use and return to True Air Technologies immediately. The units should be decontaminated and bagged with a certification of disinfection before return to True Air Technologies. True Air will provide replacement units to replace the returned units. Customers were instructed to refer to the Medical Device Recall Return Response Form attached for acknowledgement of receipt and contact information for this voluntary recall. Customers with questions should call 800-682-7163.

Device

Device Recall ECATS E 850 Bariatric Bed
  • 모델명 / 제조번호(시리얼번호)
    Serial #'s E510, 506, 503, 515, 518, 10050, 512, 519, E9141, E9150, E9160, E9149, E9137, E5107, E9162, E9165, E9170, E9147, E5323, E520, E9171. E9149, E9516, E9140, 10051, 507, 508, 502, 504, 501, 514, 522, E9139, E10099, E525, 10052, E9148, E9161, E511, E9144, E914, E526, E500, E521, E9166, E530, E529 & E9146.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including GA, KY, and MI.
  • 제품 설명
    ECATS E 850 Bariatric Bed, True Air Technologies, Inc.
  • Manufacturer
    SCM True Air Technologies LLC

Manufacturer

SCM True Air Technologies LLC
  • 제조사 주소
    SCM True Air Technologies LLC, 7955 National Tpke Unit 100, Louisville KY 40214-4903
  • 제조사 모회사 (2017)
    SCM True Air Technologies
  • Source
    USFDA