Events

Device Recall Sunrise MedicalHoyer Advance Patient Lifts 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Joerns Healthcare Inc. 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
    37641
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0727-2007
  • 사례 시작날짜
    2007-02-21
  • 사례 출판 날짜
    2007-04-07
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-10-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51204
  • 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
    Patient Lift - Product Code FSA
  • 원인
    Unapproved design change (by base supplier) consisting of a reduction in the number of mast-to-base welds (from four welds to two welds).
  • 조치
    Recall initiated by letter dated 2/21/2007. Sunrise Medical will schedule onsite appointments to complete the base replacement.

Device

Device Recall Sunrise MedicalHoyer Advance Patient Lifts
  • 모델명 / 제조번호(시리얼번호)
    1)-Model Number : Hoy - Advance - E with Serial numbers: 0601L0433 through 0601L0441, 0603L0294 through 0603L0336, 0603L0493 through 0603L0501, 0603L1011 through 0603L1021, 0603L1139 through 0603L1187, 0603L1285 through 0603L1294, 0604L0394 through 0604L0411, 0604L0885 through 0604L0941, 0604L1002 through 0604L1012, 0606L0365 through 0606L0431, 0606L0789 through 0606L0818, 0606L1006 through 0606L1030, and 0607L0001 through 0607L0090--2)Model Number: Hoy - Advance - H with Serial numbers: 0601L0442 through 0601L0459, 0603L0286 through 0603L0293, 0603L1022 through 0603L1041, 0603L1295 through 0603L1330, 0603L1519 through 0603L1572, 0605L0742 through 0605L0753, 0606L0049 through 0606L0142, 0606L0819 through 0606L0848, and 0606L1031 through 0606L1144
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution --- USA including states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and country of Canada.
  • 제품 설명
    Sunrise Medical-Hoyer Advance Patient Lifts (Portable and Folding Patient Lift) Sunrise Medical, Inc.
  • Manufacturer
    Joerns Healthcare Inc.

Manufacturer

Joerns Healthcare Inc.
  • 제조사 주소
    Joerns Healthcare Inc., 5001 Joerns Dr, Stevens Point WI 54481-5011
  • Source
    USFDA