Events

Device Recall ANSPACH Electric System Foot Control with Direction Only 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 The Anspach Effort, Inc. 에 의해 제조된 제품과 관련되어 있습니다.

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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
    63086
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0075-2013
  • 사례 시작날짜
    2012-01-09
  • 사례 출판 날짜
    2012-10-18
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-09-16
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113406
  • 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
    Drills, burrs, trephines & accessories (simple, powered) - Product Code HBE
  • 원인
    The anspach effort, inc. in palm beach gardens, fl is recalling the foot control/foot pedal due to the foot control cable lacking the shield connection from the cable to the connector body.
  • 조치
    Anspach sent an Urgent Product Removal letter dated January 9, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to contact their sales representative to facilitate the removal action by providing a replacement for the affected product. For question contact your local sales representative or the Product Support department.

Device

Device Recall ANSPACH Electric System Foot Control with Direction Only
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: E28305271001, E28305271002, E28305271003, E28305271004, E2830527100, E28305271006, E28305271007, E28305271008, E2830521009, E28305271010, E29305270901, E29305270902, E29305270903, E29305271101, E29305271102, E29305271103, E29305271104, E29305271105, E29305271106, E29305271107, E29.
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (nationwide) and the countries of: Italy, Japan, Switzerland, Turkey and Taiwan.
  • 제품 설명
    "***Electric Systems Foot Control with Direction Only***Rx Only***" || Product Usage: || Cutting and shaping bone including bones of the spine and cranium.
  • Manufacturer
    The Anspach Effort, Inc.

Manufacturer

The Anspach Effort, Inc.
  • 제조사 주소
    The Anspach Effort, Inc., 4500 Riverside Drive, Palm Beach Gardens FL 33410-4235
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • Source
    USFDA