Events

Device Recall CSeries Carry Bar 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Prism Medical Services USA 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
    65193
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1578-2013
  • 사례 시작날짜
    2013-01-27
  • 사례 출판 날짜
    2013-06-21
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118206
  • 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, ac-powered - Product Code FNG
  • 원인
    The firm replaced the recalled carry bar with a plastic insert with a carry bar with a metal insert due to improper installation of the recalled carry bars.
  • 조치
    The firm, Prism Medical, sent a letter dated January 27, 2013 to is customers.The letter described the product, problem and actions to be taken. The customers were instructed to perform an immediate safety check checking that both the pin and the plug have been inserted into the carry bar as outlined in the attached User Instruction guide. Prism offered to replace the recalled product with a different product with greater functionality. If you have any questions, contact VP-Global Product Development at 416-726-3107.

Device

Device Recall CSeries Carry Bar
  • 모델명 / 제조번호(시리얼번호)
    model number 360755
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: US (nationwide) and country of: Canada.
  • 제품 설명
    Prism Medical C-Series Carry Bar, Class I, model number 360755. || The intended use is a carry bar attached to a C-450 or C-625 ceiling lift used to lift, transfer or position clients.
  • Manufacturer
    Prism Medical Services USA

Manufacturer

Prism Medical Services USA
  • 제조사 주소
    Prism Medical Services USA, 45 Progress Pkwy, Maryland Heights MO 63043-3701
  • Source
    USFDA