Events

Device Recall SpineSix01/SpineSix02 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 BioMotion Medical Systems, 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
    63788
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0571-2013
  • 사례 시작날짜
    2012-11-12
  • 사례 출판 날짜
    2012-12-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-11-05
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114771
  • 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
    Exerciser, powered - Product Code BXB
  • 원인
    Biomotion is issuing a field correction for all models of the spinesix (spinesix01 and spinesix02; serial numbers 1001 through 1054) to rectify all regulatory deficiencies involving the former owners of the spinesix product and concurrently preparing the submission of a 510(k) application in order to receive premarket clearance for spinesix.
  • 조치
    BioMotion issued a field correction letter dated October 18, 2012 for all models of the SpineSix (SpineSix01 and SpineSix02; serial numbers 1001 through 1054) to all affected customers. The letter identified the product, problem, and actions to be taken. BioMotion is preparing the submission of a 510(k) application in order to receive premarket clearance for SpineSix. Contact the firm at 772-405-7899 for questions concerning this letter.

Device

Device Recall SpineSix01/SpineSix02
  • 모델명 / 제조번호(시리얼번호)
    serial numbers: 1001 through 1054
  • 의료기기 분류등급
    Physical Medicine Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Distributed in Florida, Georgia, Tennessee, New Jersey, New York, Pennsylvania, and Wisconsin.
  • 제품 설명
    SpineSix consists of a motorized treatment table that is controlled by an integral computer. The system is operated by means of 12-inch Color LCD touch screen that displays treatment time, positioning and magnitude and direction of motion. || There are eight fully customizable Patient Protocol settings for commonly used || treatment settings. || The SpineSix BioMotion Spinal System is intended to reproduce normal spine mechanics and physiological movements so that a patient can comfortably and safely experience functional range of motion in a non-weight-bearing environment.
  • Manufacturer
    BioMotion Medical Systems, LLC

Manufacturer

BioMotion Medical Systems, LLC
  • 제조사 주소
    BioMotion Medical Systems, LLC, 6619 North Scottsdale Rd., scottsdale AZ 85250
  • Source
    USFDA