Events

Device Recall Lift Chairs 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Pride Mobility Products 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
    29344
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0212-05
  • 사례 시작날짜
    2004-06-07
  • 사례 출판 날짜
    2004-11-19
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2006-08-10
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33575
  • 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
    Chair, Positioning, Electric - Product Code INO
  • 원인
    The heating pad on these lift chairs may tear at the entry point causing a short and/or overheating, which can damage the chair.
  • 조치
    The recalling firm sent a Safety Alert notification to their direct accounts on 5/14/04 informing them of the problem. The direct accounts were instructed to locate the end user and inform them of the problem. Once the chair has been located the direct account is to contact the recalling firm for a replacement and return the recalled chair.

Device

Device Recall Lift Chairs
  • 모델명 / 제조번호(시리얼번호)
    Model Numbers: C20, C30, GL358S, GL358L, TMR58, TMR540, TMR560, TMR570T, TMR571, TMR585, DMR670, TMR805, and TMR450.
  • 의료기기 분류등급
    Physical Medicine Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    The recalled product was distributed through dealers nationwide. The affected states are as follows: AL, AR, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, LA, OH, OK, MA, MD, MI, MN, MO,MS, NC, ND, NE, NH, NJ, NM, NV, NY, PA, SC, TN, TX, UT, VA, VT, WA, and WV . There is one government account in FL.
  • 제품 설명
    Lift Chairs. Electric Positioning Chair.
  • Manufacturer
    Pride Mobility Products Corp

Manufacturer

Pride Mobility Products Corp
  • 제조사 주소
    Pride Mobility Products Corp, 182 Susquehanna Avenue, Exeter PA 18643
  • Source
    USFDA