Events

Device Recall Life Force Chamber 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Life Force of Tampa, LLC 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
    69043
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2625-2014
  • 사례 시작날짜
    2014-06-27
  • 사례 출판 날짜
    2014-09-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-07-30
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129390
  • 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
    Chamber, patient isolation - Product Code LGM
  • 원인
    The life force chamber is marketed and promoted as a medical device, intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body. life force of tampa does not have an approved application for premarket approval in effect, or an approved application for an investigat.
  • 조치
    Life Force of Tampa LLC sent an URGENT: MEDICAL DEVICE RECALL letter dated June 27, 2014 to all affected customers. The letter instructed the customers to: 1) Immediately remove and discard all copies of the labeling material. 2) Remove all electronic copies of the materials from any publicly accessible locations (e.g. website). 3) Complete and return the Acknowledgment form to Life Force of Tampa. For questions or concerns contact Douglas G. Cornell at (813) 961-4655.

Device

Device Recall Life Force Chamber
  • 모델명 / 제조번호(시리얼번호)
    ALL Life Force Chambers
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution in the states of AZ, FL, MD, NV, OK, PA, and TX.
  • 제품 설명
    Life Force Chamber || Product Usage:The product is intended for restful contemplation and spirituality.
  • Manufacturer
    Life Force of Tampa, LLC

Manufacturer

Life Force of Tampa, LLC
  • 제조사 주소
    Life Force of Tampa, LLC, 4125 Gunn Hwy Ste B1, Tampa FL 33618-8788
  • Source
    USFDA