Breeze C Scooters 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Afikim Electric Vehicles 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 날짜
    2013-10-02
  • 사례 출판 날짜
    2013-10-02
  • 사례 국가
  • 사례 출처
    DH
  • 사례 출처 URL
  • 비고 / 경고
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • 데이터 추가 비고
    Medical Device Safety Alert
  • 원인
    Medical device safety alert: afikim breeze c scooters the united states food and drug administration (fda) has issued a medical device safety alert concerning breeze c scooters, manufactured by afikim electric vehicles. the affected products are identified as follows:- serial no.: 10390024, 11390060, 11490426, 12390107, 12490181, 10390025, 11390061, 11490433, 12390117, 12490182, 10390029, 11390069, 11490435, 12390120, 12490183, 10390030, 11390074, 11490445, 12490169, 12490184, 10390034, 11390095, 12390096, 12490170, 12490185, 10390037, 11390101, 12390097, 12490172, 12490186, 10490100, 11490111, 12390098, 12490173, 12490187, 10490108, 11490147, 12390099, 12490174, 12490188, 10490111, 11490176, 12390101, 12490175, 12490189, 10490113, 11490189, 12390102, 12490176, 12490190, 10490119, 11490277, 12390103, 12490177, 12490191, 10490121, 11490304, 12390104, 12490178, 12490192, 10490124, 11490305, 12390105, 12490179, 12490193, 11390058, 11490425, 12390106, 12490180 the products were manufactured from 02/07/2010 to 24/07/2012 and distributed from 15/09/2010 to 25/07//2013. during product testing, the manufacturer became aware of a potential scenario where an internal potentiometer wiper could become disconnected due to extensive wear. if this were to occur the device could continue to drive forward at a slow speed of approximately 2-4 mph and the only way to stop the device would be by turning off the main key switch. there is no injuries have been reported to date. the manufacturer is notifying its distributors and customers by telephone and/or email and is arranging for correction of all affected products. for details, please visit the following fda websites: http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm370577.Htm http://www.Fda.Gov/safety/recalls/ucm370503.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 2 october 2013.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Afikim Breeze C Scooters
  • Manufacturer

Manufacturer