Events

Device Recall Invacare Storm TDX Power Wheelchair 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Invacare 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
    37929
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0966-2007
  • 사례 시작날짜
    2007-03-19
  • 사례 출판 날짜
    2007-07-04
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-09-27
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=52257
  • 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
    Power Wheelchair - Product Code ITI
  • 원인
    Software error may permit the chair to recline too far.
  • 조치
    The recalling firm sent a recall letter dated March 19, 2007. The recalling firm also posted information regarding the recall on their website.

Device

Device Recall Invacare Storm TDX Power Wheelchair
  • 모델명 / 제조번호(시리얼번호)
    06JE002273, 06JE002762, 06JE003580, 06JE003583, 06JE003584, 06JE003585, 06JE003597, 06JE003598, 06JE003880, 06JE003890, 06JE004170, 06JE004172, 06JE004178, 06JE004196, 06JE004632, 06JE004640, 06JE005420, 06JE005421, 06JE005864, 06JE005870, 06JE005871, 06JE005879, 06JE005885, 06JE006254, 06JE006277, 06JE006599, 06JE006603, 06JE006612, 06JE007087, 06JE007393, 06JE007396, 06JE007403, 06JE007408, 06JE007818, 06JE008028, 06JE008311, 06JE008322, 06JE008324, 06JE008329, 06JE008330, 06JE008332, 06JE008350, 06JE008670, 06JE008678, 06JE009028, 06JE009031, 06JE009039, 06JE009040, 06JE009042, 06JE009060, 06JE009062, 06JE009076,  06KE000147, 06KE000149, 06KE001924, 06KE001933, 06KE002243, 06KE002264, 06KE002265, 06KE002267, 06KE002270, 06KE002851, 06KE002853, 06KE002858, 06KE002862, 06KE003116, 06KE003379, 06KE003381, 06KE003386, 06KE003612, 06KE004451, 06KE004454, 06KE004455, 06KE004467, 06KE004854, 06KE005538, 06KE005826, 06KE006063, 06KE006065, 06KE006333, 06KE006613, 06KE006876, 06KE006877, 06KE006886, 06KE006894, 06KE007257, 06KE007282, 06KE007294, 06KE007450, 06KE007684, 06KE007686, 06KE007689, 06KE008610, 06KE008611, 06LE000170, 06LE000173 06LE001305, 06LE001313, 06LE001527, 06LE001694, 06LE001696, 06LE001697, 06LE001705, 06LE001998, 06LE002608, 06LE003258, 06LE003261, 06LE003267, 06LE003268, 06LE003462, 06LE003466, 06LE003987, 06LE004643, 06LE004650, 06LE004846, 06LE004857, 06LE005143, 06LE005144, 06LE005148, 06LE005152, 06LE005154, 06LE005732, 06LE005895, 06LE006012, 06LE006013, 06LE006024, 06LE006704, 06LE006707, 06LE006709, 06LE007018, 06LE007210, 06LE007358, 06LE007371, 06LE007379, 06LE007387, 06LE007393, 06LE007397, 06LE007403, 06LE007404, 07AE000983, 07AE001149, 07AE001180, 07AE001326, 07AE001327, 07AE001334, 07AE001594, 07AE001595, 07AE002009, 07AE002013, 07AE002223, 07AE002225, 07AE002229, 07AE002400, 07AE002404, 07AE002670, 07AE002683, 07AE002990, 07AE003522, 07AE003700, 07AE003712, 07AE003713, 07AE003716, 07AE004618, 07AE005103, 07AE005337, 07AE005339, 07AE005340, 07AE005341, 07AE005586, 07AE005593, 07AE005597, 07AE005886, 07AE005887, 07AE005895, 07AE006089, 07AE006303, 07AE006308, 07AE006314, 07AE006927, 07AE006930, 07AE007089, 07AE007090, 07AE007091, 07AE007092, 07AE007103, 07AE007105, 07AE007113, 07AE007114, 07AE007326, 07AE007327, 07AE007331, 07AE007334, 07AE007598, 07AE007606, 07AE007607, 07AE007611, 07AE007612, 07BE001073, 07BE001076, 07BE001077, 07BE001078, 07BE001082, 07BE001093, 07BE001303, 07BE001309, 07BE001310, 07BE001578, 07BE001585, 07BE001806, 07BE001810, 07BE002005, 07BE002014, 07BE002015, 07BE002253, 07BE002254, 07BE003336, 07BE003337, 07BE003569, 07BE003574, 07BE003582, 07BE003584, 7BE003585, 07BE004719, 07BE004907, 07BE004913, 07BE004916, 07BE006332.
  • 의료기기 분류등급
    Physical Medicine Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide and Canada.
  • 제품 설명
    Invacare Storm TDX Power Wheelchair, Models: #TDX3-PS, TDX3-SE-PS, TDX4-PS.
  • Manufacturer
    Invacare Corporation

Manufacturer

Invacare Corporation
  • 제조사 주소
    Invacare Corporation, 1 Invacare Way, PO Box 4028, Elyria OH 44035
  • Source
    USFDA