Device Recall microTargeting Drive 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 FHC, 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
    55287
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0313-2011
  • 사례 시작날짜
    2010-03-30
  • 사례 출판 날짜
    2010-11-03
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2015-02-25
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    neurological stereotaxic instrument - Product Code HAW
  • 원인
    Fixation thumbscrew on the dbs depth stop adapter may be overtightened and damage the implantable lead.
  • 조치
    FHC issued an "URGENT: MEDICAL DEVICE CORRECTION" letter dated March 29, 2010, to all customers. The letter described the product, problem and actions to be taken by the customers. FHC informed the customers that that they had returned to the original design of the fixation screw in the Depth Stop Adapter. FHC sent replacement Depth Stop Adapter with an original fixation screw. The customers were instructed to discard the recalled Depth Stop Adapter (s) and replace with the enclosed corrected version(s) and sign and fax the receipt notification to 207-666-8309 as proof of their receipt of notification. For assistance with the product replacement, contact the FHC's technical support line at 800-326-2905. This line is staffed 24 hours a day. Should you have any further questions regarding this matter, please contact Dorothee Sasse, product manager, or Keri Seitz, recall coordinator at 207-666-8190.

Device

  • 모델명 / 제조번호(시리얼번호)
    Not serialized. Manufactured after January 21, 2010 and prior to March 22, 2010.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA in the states of AZ, CA, FL, ID, NC, MA, MI, MN, NV, RI, UT, VA, and WA, and countries of Columbia and South Africa.
  • 제품 설명
    microTargeting Drive DBS Lead Holder 66-CN-DB || Product is the FHC DBS Depth Stop Adapter, a component of the microTargeting Drive and the STar Drive. The Drives are intended to be used with commercially available stereotactic systems for neurosurgical procedures which require the accurate positioning of microelectrodes, stimulating electrodes, or other instruments in the brain or nervous system.
  • Manufacturer

Manufacturer

  • 제조사 주소
    FHC, Inc., 1201 Main Street, Bowdoinham ME 04008
  • 제조사 모회사 (2017)
  • Source
    USFDA