Device Recall Encore Mobile Patient Lifter 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Arjo, Inc. dba ArjoHuntleigh 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
    62116
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1947-2012
  • 사례 시작날짜
    2012-06-29
  • 사례 출판 날짜
    2012-07-06
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2018-03-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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, non-ac-powered - Product Code FSA
  • 원인
    Arjohuntleigh has received a limited number of customer reports concerning injuries related to an exposed metal support bracket when the proactive knee pad assembly is removed.
  • 조치
    ArjoHuntleigh sent an "URGENT FIELD CORRECTION RECALL" notice dated June 25, 2012, to all affected customers via UPS Ground on June 29, 2012. The notice informed the accounts of the potential for severe patient injury if the proactive knee pad support is removed from the lift without the removal of the knee pad support bracket. The accounts were reminded that the entire knee pad and support bracket assembly must be removed from the lift when required to do so for exercise. An additional warning statement with diagrams was included in the notice. The accounts were requested to disseminate the information to all users of the affected lifts, to include a copy of the notice in the Instruction for Use Manuals for their lifts, and to complete the Customer Response Form online, using the enclosed card's instructions. Questions were directed to the ArjoHuntleigh at 1-800-323-1245, ext 57985.

Device

  • 모델명 / 제조번호(시리얼번호)
    Models KKB5022-21US, serial numbers 010390894401, 010390894402, 010390894403, 010390894405, 010390894408, 010390894410, 020390958503, 030186208608, 030186208609, 030186208610,  030186208701, 030186208702, 030186208704, 030186208705, 030186208706, 030186208707, 030186208708, 030186208709, 030186208710, 030186208801, 030186208802, 030186208803,  030186208804, 030186208810, 030186208903, 040186294405, 040186453504, 040186453507, 040186453508, 040186453509, 040391134003, 040391134004, 040391134005, 040391134006,  040391134007, 040391134008, 040391134009, 050186453403, 050186453404, 050186453405, 050186453406, 050186453407, 050186453408, 050186453409, 050186453410, 050186453601,  050186453602, 050186453603, 050186453604, 050186453605, 050186453606, 050186453607, 050186453608, 050186453609, 050186453610, 050288869704, 050288869705, 050288869706,  050288869707, 050288869708, 050288869709, 050288869710, 050288888001, 050288888002, 050288888003, 050288888004, 050288888005, 050288888006, 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GB240436838T,  GB240436839T, GB240437517T, GB240437518T, GB240438478T, GB240438479T, GB240438480T, GB270444518T, GB270444519T, GB270444520T, GB270444521T, GB280445596T, GB280446659T,  GB290447966T, GB290447967T, GB290447968T, GB290447969T, GB290447970T, GB290447971T, GB290447972T, GB290447973T, GB290447974T, GB290447975T, GB290448062T, GB290448063T,  GB290448064T, GB290448065T, GB290448066T, GB300448458T, GB300448459T, GB300449263T, GB300449265T, GB300449266T, GB300449267T, GB300449268T, GB300449269T, GB300449270T,  GB310450735T, GB320451842T, GB320451843T, GB320451844T, GB320451847T, GB320451849T, GB330453171T, GB330453172T, GB330453173T, GB330453176T, GB340455504T, GB340455505T,  GB400463858T, GB400463859T, GB400463860T, GB400463861T, GB400463862T, GB440473707T, GB440473708T, GB440473709T, GB440473710T, GB470479722T, GB470479723T, GB470479724T,  GB470479726T, GB470479727T, GB470479728T, GB470479729T, GB470479730T, GB470480473T, GB470480474T, GB470480475T, GB470480477T, GB470480478T, GB470480479T, GB470480480T,  GB470480481T, GB470480707T, GB470480708T, GB470480709T, GB470480710T, GB470480711T, GB470480712T, GB470480713T, GB470480714T, GB470480715T, GB480405320T, GB480405321T,  GB480405322T, GB480405323T, GB480405324T, GB480480963T, GB490407629T, GB490407630T, GB490407631T, GB490407632T, GB490407633T, GB490407634T, GB490407635T, GB490407636T,  GB490407637T, GB490407990T, GB490407991T, GB490407992T, GB490407993T, GB490407995T, GB490407996T, GB490407997T, GB490408366T, GB490408367T, GB490408368T, GB490408369T,  GB490408370T, GB490408371T, GB490408372T, GB490408373T, GB490408374T, GB490408375T, GB490408376T, GB490408377T, GB490408378T, GB490408379T, GB490408380T, GB490408381T,  GB490408382T, GB490408383T, GB490408384T, GB490408385T, GB490408386T, GB490408388T, GB490408389T, GB490408390T, GB490408391T, GB490408392T, GB490408393T, GB490408394T and  GB490408395T;  and Model KKB5042-21US, serial numbers 020493491301, 020493491303, 020493491304, 020493491305, 020493491306, 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  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) and the countries of Australia, Austria, Belgium, Bermuda, Canada, Cyprus, Czech Republic, Denmark, Dubai, Estonia, Finland, France, Germany, Gibraltar, Great Britain, Greece, Hong Kong, Iceland, Ireland, Israel, Italy, Japan, Kenya, Korea, Luxembourg, the Netherlands, New Zealand, Northern Ireland, Norway, Poland, Portugal, Quatar, Saudi Arabia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland and Turkey
  • 제품 설명
    Encore Mobile Patient Lifter; manufactured by Arjo Ltd., St. Catherine Street, Gloucester, GL1 2SL, England, U.K.; Models KKB5022-21US and KKB5042-21US. || The Encore is designed to be used as a standing and raising aid, it is useful for short transfers from one sitting position to another, and to elevate a patient for toileting, repositioning, changing of incontinence pads or wound dressings, standing practice etc. it is not intended for long periods of suspension or transportation.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Arjo, Inc. dba ArjoHuntleigh, 2349 W Lake St, Addison IL 60101-6183
  • 제조사 모회사 (2017)
  • Source
    USFDA