Events

Device Recall Stryker Medical StairPRO Evacuation Chair 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Stryker Medical Div. of Stryker Corporation 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
    50178
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0650-2009
  • 사례 시작날짜
    2008-11-18
  • 사례 출판 날짜
    2009-02-04
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-10-27
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=75006
  • 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 transport device, - Product Code FPP
  • 원인
    Handle could come off. the bolts may back out over time, resulting in a risk of dropping the patient and/or injury to transport personnel, a delay in medical treatment, or a delay in evacuation.
  • 조치
    Consignees were notified by Urgent Medical Device Correction letter dated 11/18/08 and given the serial numbers of their units, an upgrade kit and instructions for performing replacement of the bolts. Consignees were informed Stryker will perform the upgrade if requested.

Device

Device Recall Stryker Medical StairPRO Evacuation Chair
  • 모델명 / 제조번호(시리얼번호)
    Serial numbers 080940895, 080940896, 080940578, 080940614, 080940615, 080940616, 080940618, 080940619, 080940620, 080940621, 080940623, 080940624, 080940625, 080940626, 080940628, 080940880, 080940571, 080940572, 080940573, 080940574, 080940575, 080940576, 080940629, 080940630, 080940599, 080940554, 080940555, 080940887, 080940888, 080940889, 080940890, 080940891, 080940892, 080940893, 080940894, 800940881, 080940772, 080940773, 080940774, 080940564, 080940565, 080940566, 080940850, 080940856, 080940556, 800940557, 080940558, 080940559, 080940560, 080940561, 800940562, 080940563, 080940633, 080940634, 080940635, 080940636, 080940245, 080940246, 080940851, 080940852, 080940853, 080940854, 080940846, 080940847, 080940848, 080940849, 080940810, 080940811, 080940812, 080940813, 080940814, 080940815, 080940577, 080940631, 080940632, 080940617, 080940622, 080940627, 080940818, 080940857, 080940882, 080940897, 080940816, 080940817, 080940567, 080940568, 080940569, 080940570, 080940579, 080940800, 080940801, 080940802, 080940878, 080940879, 080940855, 080940883, 080940884, 080940885, 080940886, 080940637, 080940638 and 080940803.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: USA, India, Netherlands and United Kingdom.
  • 제품 설명
    Stryker Medical Stair-PRO Evacuation Chair civilian use stair chair, patient transport device, Model 6253.
  • Manufacturer
    Stryker Medical Div. of Stryker Corporation

Manufacturer

Stryker Medical Div. of Stryker Corporation
  • 제조사 주소
    Stryker Medical Div. of Stryker Corporation, 3800 E. Centre Ave., Portage MI 49002
  • Source
    USFDA