Events

Device Recall AlterG AntiGravity Treadmill 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 AlterG, 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
    67435
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1131-2014
  • 사례 시작날짜
    2014-01-28
  • 사례 출판 날짜
    2014-03-04
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-05-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125448
  • 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
    Treadmill, powered - Product Code IOL
  • 원인
    Unapproved material used by vendor in subset of shorts causing them to stretch more than usual and are uncomfortable for patient.
  • 조치
    The firm, AlterG, Inc, sent "Medical Device Recall Notification Anti-Gravity Short Exchange" letters dated February 6, 2014 to all customers beginning February 7, 2014 by Federal Express. The letter describes the product, problem and actions to be taken. The customers were instructed to review your inventory of shorts to identify any that are labeled ZIN1212 or ZIN0413 and return any shorts with these labeled production date using the return label provided. If you have any questions about this shorts exchange program or if there are any other ways we can be of assistance to you, please email us at support@alterg.com or call the support team at any time at 510-2705369.

Device

Device Recall AlterG AntiGravity Treadmill
  • 모델명 / 제조번호(시리얼번호)
    Product M320, Accessory Shorts with lot numbers XIN1212, XIN0413, XIN0213, XIN0313 and XIN0413,
  • 의료기기 분류등급
    Physical Medicine Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution:US (nationwide) and to countries: Australia, Netherlands, United Kingdom, Spain, Germany, France, Denmark, Switzerland, Poland, Slovak Republic, Austria, and United Arab Emirates.
  • 제품 설명
    Accessory shorts for the AlterG Anti-Gravity treadmill. || Use with the AlterG Anti-Gravity Treadmill for rehabilitation.
  • Manufacturer
    AlterG, Incorporated

Manufacturer

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