Events

WalkAide Stimulator System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Innovative Neurotronics, 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
    52049
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1435-2009
  • 사례 시작날짜
    2008-08-06
  • 사례 출판 날짜
    2009-06-03
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2009-07-28
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81991
  • 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
    Stimulator, Neuromuscular, External Functional - Product Code GZI
  • 원인
    Knob responsible for regulating the amount of stimulation administered by the walkaide system control unit may fall off while device is in use.
  • 조치
    Innovative Neurotronics Inc notified the consignee via e-mail on August 6, 2008 of the affected product. The Consignee was asked to place a stop shipment on the WalkAides and to return inventory for replacement. Further questions can be directed to Innovative Neurotronics Inc at 1-512-721-1906.

Device

WalkAide Stimulator System
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: 161024, 161471, 161971, 162121, 162149, 163264, 163424, 163586, 163844, 164343, 164647, 164816, 165459, 166074, 166583, 166725, 167715, 167788, 170292, 170309, 170407, 170425, 170434, 170452, 170523, 170532, 170694, 170701, 170747, 170916, 171040, 171139, 171219, 171362, 171371, 171371, 222093, 222137, 222173, 222235, 222244, 222333, 222379, 222388, 222413, 222431, 222468, 222477, 222502, 222539, 222584, 222593, 222600, 168054, 168072, 168090, 168107, 168116, 168134, 168143, 168189, 168483, 168929, 169357, 169562, 169660, 169893, 170041, 170121, 170238, 220755, 220808, 220960, 221174, 221209, 221263, 221290, 221325, 221389, 221923, 221932, 221941, 221950, 221969, 222048, 222057, 222075, 167813, 167822, 167895, 167902, 167911, 167920, 167939, 167948, 167957, 167966, 167975, 167993, 168009, 168036, 222548, 222575, 167742, 172218, 172343, 203809, 204031, 204273, 204344, 204406, 204415, 204442, 205003, 205236, 208966, 220700, 220728, 169919, 169937, 171433, 222646, 222655, 222673, 222717, 222726, 222735, 222744, 222753, 222799, 222815, 222824, 222922, 222931, 222959, 221996, 222002 and 171442.
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution to the state of GA.
  • 제품 설명
    WalkAide Stimulator System Control Module, Part Number 20-0100; component of the WalkAide Stimulator System; distributed by Innovative Neurotronics, Austin, TX 78746. || The WalkAide is a battery operated, single channel electrical stimulator that is used to improve walking ability by stimulating a foot lift at the appropriate time during the step cycle.
  • Manufacturer
    Innovative Neurotronics, Inc.

Manufacturer

Innovative Neurotronics, Inc.
  • 제조사 주소
    Innovative Neurotronics, Inc., 3600 North Capital of Texas Hwy, Bldg B Ste 150, Austin TX 78746
  • Source
    USFDA