Events

Device Recall GTrainer 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Alter-G, Incorporated 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
    59408
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-3026-2011
  • 사례 시작날짜
    2011-07-15
  • 사례 출판 날짜
    2011-08-16
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-08-16
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102672
  • 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
    Potential installation error on alterg anti-gravity treadmill that could cause greater than expected unweighting.
  • 조치
    Alter-G, Inc. notified all affected customers by telephone, e-mail and followed by a "Medical Device Customer Advisory Notification" letter dated July 15, 2011. Customers were provided information on the installation error, the potential harm to patients, and the actions to be taken. The letter instructs customers to discontinue use of the Alter G until the recalling firm can evaluate the machine and correct any installation error. The letter states that the recalling firm is planning to visit affected customer's facility as quickly as possible and will contact customers to schedule this visit. Questions or concerns should be directed to David Tjon at 510-270-5369.

Device

Device Recall GTrainer
  • 모델명 / 제조번호(시리얼번호)
    Model # Model M320: Serial Numbers: FIT00574, FIT00631, FIT00599, FIT00575, FIT00624, FIT00628, FIT00699, FIT00860, FIT00859, FIT00857, FIT00611, FIT00632, FIT00738, FIT00777, FIT00779, FIT00847.
  • 의료기기 분류등급
    Physical Medicine Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution (USA ) - including the states of: OK and TX.
  • 제품 설명
    AlterG Anti-Gravity Treadmill; || Alter G, 48349 Milmont Drive, Fremont, Ca 94538 || Product Usage: Rehabilitation of lower body injury & Neurological conditions.
  • Manufacturer
    Alter-G, Incorporated

Manufacturer

Alter-G, Incorporated
  • 제조사 주소
    Alter-G, Incorporated, 48438 Milmont Dr, Fremont CA 94538-7326
  • 제조사 모회사 (2017)
    AlterG Inc.
  • Source
    USFDA