Events

Device Recall P600 Portable Lift 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 ErgoSafe Products, LLC (DBA) Prism Medical 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
    71376
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2270-2015
  • 사례 시작날짜
    2015-06-24
  • 사례 출판 날짜
    2015-07-27
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-04-03
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137576
  • 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
    Lift, patient, non-ac-powered - Product Code FSA
  • 원인
    There is a potential the sling loops may not stay attached to the carry bar hooks.
  • 조치
    Prism Medical sent a Field Safety Notice to affected customers via certified first class US mail. The notice identified the affected product, problem and actions to be taken. For questions contact your local Prism Medical dealer or Prism Medical Customer Service Representative 1-800-891-6502

Device

Device Recall P600 Portable Lift
  • 모델명 / 제조번호(시리얼번호)
    All serial numbers.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide and the countries of:Canada, Great Britain, Australia, South Korea, and Japan.
  • 제품 설명
    Prism Medical P-600 Portable Ceiling Lift; PN 303090. Patient lift with weight specification of 600 lbs (273 kg). || Product Usage: || The P-600 lift is a lifting aid used by health care professionals and those providing care in the home to lift, position, and transfer clients or a disabled family member. The ceiling lift makes it possible to move mobility impaired individuals with minimal strain or risk to the caregiver, while providing complete safety, dignity, and comfort for the client or family member.
  • Manufacturer
    ErgoSafe Products, LLC (DBA) Prism Medical

Manufacturer

ErgoSafe Products, LLC (DBA) Prism Medical
  • 제조사 주소
    ErgoSafe Products, LLC (DBA) Prism Medical, 10888 Metro Ct, Maryland Heights MO 63043-2413
  • 제조사 모회사 (2017)
    Triona Holding Sa
  • Source
    USFDA