Events

Device Recall Anspach 4 mm Fluted Ball for MRI 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
    64247
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1907-2014
  • 사례 시작날짜
    2012-11-28
  • 사례 출판 날짜
    2014-06-25
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-08-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115891
  • 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
    Motor, drill, pneumatic - Product Code HBB
  • 원인
    The anspach effort, inc. in palm beach gardens, fl is recalling their anspach custom devices. the units were not manufactured consistently with quality system requirements.
  • 조치
    The Anspach Effort, Inc. sent an Urgent Medical Device Recall letter dated December 21, 2012 to all affected customers. The letter identified the affected products, problems and actions to be taken. Customers were instructed to remove and return the affected products and complete the attached reply form and return to The Anspach Effort Inc. For questions contact Anspach Product Support at (800) 327-6887. For questions regarding this recall call 561-494-3706.

Device

Device Recall Anspach 4 mm Fluted Ball for MRI
  • 모델명 / 제조번호(시리얼번호)
    Part Number: SP-3014-00; Serial Numbers: 200141, 200118, 200119, 200121, 200122, 200058, 200048, 200142, 200057, 200047, 200077, 200049, 200120.
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .
  • 제품 설명
    ANSPACH***REF SP-3014-00***4mm Fluted Ball for MRI***Rx Only*** || This device is intended to be used with Anspach Systems
  • 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