Events

Rascal UltraLite Scooter Model 370B 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Electric Mobility Corp 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
    56978
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0417-2011
  • 사례 출판 날짜
    2010-11-18
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-04-03
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95194
  • 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
    Vehicle, motorized 3-wheeled - Product Code INI
  • 원인
    Scooter seat bases were found to have insufficient welding which may lead to the seat base becoming loose and causing the seat to wobble. this may result in complete failure of the seat base, causing the user to fall off the vehicle.
  • 조치
    The Rascal Company (Electric Mobility Corporation) sent Urgent Medical Device Recall Notice Scooter Seat Base letters dated October 7, 2010 and November 11, 2010 letter to their affected retail customers and affected dealers. The letter instructs the reader that the seat base may become loose, causing the seat to wobble and if not replaced the wobble could lead to a complete failure of the seat base and cause an individual to fall off their vehicle and become injured. The letters also instruct the reader to replace seat bases immediately. Respone forms are attached. Seats with new seat bases will be shipped with return shipping labels to return the original base to the factory. Service representatives will replace the seat base for customers. Customers can contact the Rascal Company about this recall at 1-800-662-4548.

Device

Rascal UltraLite Scooter Model 370B
  • 모델명 / 제조번호(시리얼번호)
    No expiration date; 510 K - K002616; Device Listing #E394292; UL370B, EMC Part #42021011, EMC Part #42021012
  • 의료기기 분류등급
    Physical Medicine Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: Throughout the US and Canada
  • 제품 설명
    Rascal UltraLite 370B manufactured by Giant Manufacturing, Taiwan.
  • Manufacturer
    Electric Mobility Corp

Manufacturer

Electric Mobility Corp
  • 제조사 주소
    Electric Mobility Corp, 599 Mantua Boulevard, One Mobility Plaza, Sewell NJ 08080
  • Source
    USFDA