Events

Device Recall Amico ECylinder Canister Holder 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Stryker Communications 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
    52099
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1569-2009
  • 사례 시작날짜
    2009-05-19
  • 사례 출판 날짜
    2009-07-13
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-04-26
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82092
  • 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
    E-Cylinder Canister Holder - Product Code BRY
  • 원인
    Design flaw on the e-cylinder canister holder may result in early fatigue and failure of the bracket screws, which could cause the cage to become detached from its mount and fall.
  • 조치
    An "Urgent: Device Recall" letter dated May 19, 2009 was issued to customers. Customers were advised to discontinue use of all affected E-cylinder holders. Consignees were asked to return the "Product Accountability Form" included with the recall letter, after which consignees will be provided with an improved cylinder holder at no cost. Direct questions to Stryker Communications at 1-972-410-7100.

Device

Device Recall Amico ECylinder Canister Holder
  • 모델명 / 제조번호(시리얼번호)
    Catalog/Product Number: 0682-001-111 and 0682-000-449.  All E-Cylinder canister holders shipped between 01 JAN 05 and 27 SEP 06.
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide and Canada.
  • 제품 설명
    Amico E-Cylinder Canister Holder, distributed by Stryker Communications, Flower Mound, TX 75028. || Canister holder is used to hang E-Cylinders (pressurized gas canisters) from a boom. Product typically used in the surgical setting.
  • Manufacturer
    Stryker Communications Corp

Manufacturer

Stryker Communications Corp
  • 제조사 주소
    Stryker Communications Corp, 1410 Lakeside Pkwy Ste 100, Flower Mound TX 75028-4026
  • 제조사 모회사 (2017)
    Stryker
  • Source
    USFDA