Events

Device Recall Stryker InTouch Critical Care Bed 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
    49610
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0941-2009
  • 사례 시작날짜
    2009-01-05
  • 사례 출판 날짜
    2009-02-25
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-11-05
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74681
  • 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
    ELECTRIC ICU BED; MULTIPLE - Product Code FNL
  • 원인
    The touch screen on the footboard may display a "tilt over range" error, resulting in a precautionary stop of the bed motions which result in the bed appearing to have locked out some of its bed positioning features.
  • 조치
    Consignees were notified of the problems via letter dated January 5, 2009, advised to check their beds and to take them out of service if the foot board touchscreen displayed a "tilt over range" error, and that a Stryker Medical field service representative would contact them to perform software upgrades on the affected beds. Please direct questions to Stryker Medical at 1-269-324-6644.

Device

Device Recall Stryker InTouch Critical Care Bed
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: T01014, T01015, T01016, T01017, T01018, T01019, T01020, T01021, T01022, T01023, T01024, T01025, T01026, T01027, T01028, T01029, T01030, T01031, T01032, T01033, T01034, T01035, T01036, T01038, T01039, T01040, T01041, T01042, T01043, T01044, T01045, T01046, T01047, T01048, T01049, T01050, T01051, T01052, T01053, T01054, T01055, T01056, T01057, T01059, T01060, T01061, T01062, T01063, T01064, T01065, T01067, T01068, T01069, T01070, T01071, T01072, T01073, T01074, T01075, T01076, T01078, T01079, T01080, T01081, T01082, T01083, T01084, T01085, T01086, T01087, T01088, T01089, T01090, T01091, T01092, T01093, T01094, T01095, T01096, T01098, T01100, T01101, T01102, T01103, T01104, T01105, T01106, T01107, T01108, T01109, T01110, T01111, T01112, T01113, T01114, T01115, T01116, T01117, T01118, T01119, T01120, T01121, T01122, T01123, T01124, T01125, T01126, T01127, T01128, T01129, T01130, T01131, T01132, T01133, T01134, T01135, T01136, T01137, T01138, T01139, T01140, T01141, 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T02382, T02383, T02384, T02385, T02386, T02387, T02388, T02389, T02390, T02391, T02392, T02455, T02469, T02505, T02575, T02576, T02577, T02578, T02579, T02580, T02581, T02582, T02583, T02584, T02585, T02586 and T02661.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution including USA and countries of Canada, Japan and Switzerland.
  • 제품 설명
    Stryker InTouch 1.0 Zoom Critical Care Bed (Model 2140) with the Integrated PositionPro mattress (Model 2920) option. || The device is intended to be used as an Intensive Care Unit bed.
  • 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