Events

Foot Pedal 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.

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
    53073
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0083-2010
  • 사례 시작날짜
    2009-08-13
  • 사례 출판 날짜
    2009-10-28
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-01-05
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84580
  • 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. is recalling the foot control/ foot pedal for sc2000 and sc2100 powered, simple cranial drills, burrs, trephines, and accessories. the foot control cables lacks the shield connection from the cable to the connector body. the lack of shielding may result in radiated emissions which could possibly cause interference on other electrical equipment adjacent to the foot pedal.
  • 조치
    Anspach issued an "Urgent Product Removal" Letter dated August 17, 2009 informing customers of the affected product. Consignees are asked to screen their inventory and return any affected product including a completed Product Replacement Form to the firm. For further questions, contact Anspach at 1-800-327-6887 or 1-561-627-1080.

Device

Foot Pedal
  • 모델명 / 제조번호(시리얼번호)
    EMAX2-FP Serial Numbers: C26302250301, C26302250302, C26302250303, C26302250304, 5044044307, 31495607, 32380602, 31832209, 31832202 and 32366805; and  EPLUS-FP Serial Numbers: C26302200804 , C26302200802, C27302221701 and C08301701901.
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- Canada, Indonesia, United Kingdom, Korea and United States (NC, OK, TN, CA, KS, MI and WA).
  • 제품 설명
    Foot Pedal, Foot Control for SC2000 and SC2100 Powered, simple cranial drills, burrs, trephines, and their accessories. Catalog Numbers: EMAX2-FP and FPLUS-FP. || Indicated to cut and shape 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