Events

Device Recall Medline Strider Midi 3 Scooter 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Medline Industries 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
    36171
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-1522-06
  • 사례 시작날짜
    2006-07-20
  • 사례 출판 날짜
    2006-09-23
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2009-09-02
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48122
  • 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
    scooter - Product Code INI
  • 원인
    The p&g; solo 60a electronic control unit on the midi scooters may overheat.
  • 조치
    Medline sent 'Voluntary Field Correction' letters dated 7/20/06 to the direct accounts on the same date, informing them that the Strider Midi 3 and Midi 4 scooters have an older version of the electronic control unit that may overheat, which Medline will replace with a newer version of the controller. Any questions were directed to 800-289-9793, press 1, then press 3 and ask to transfer to 4674 (8:00 AM to 5:00 PM CST).

Device

Device Recall Medline Strider Midi 3 Scooter
  • 모델명 / 제조번호(시리얼번호)
    model MDS807500 - red and model MDS807500B - blue, scooter no., controller no.: EV10DB-*US00110*,13010613; EV10DB-*US00102*,13010615; EV10DB-*US00103*,53010802; EV10DB-*US00101*,53010803; EV10DB-*US00106*,53010806; EV10DB-*US00107*,53010807; EV10DB-*US00111*,53011072; EV10DB-*US00118*,53050871; EV10DB-*US00112*,53050872; EV10DB-*US00115*,53050873; EV10DB-*US00116*,53050874; EV10DB-*US00117*,53050875; EV10DB-*US00105*,73010706; EV10DB-*US00108*,73010710; EV10DB-*US00109*,73010711; EV10DB-*US00119*,73050684; EV10DB-*US00113*,73050685; EV10DB-*US00120*,73050686; EV10DB-*US00121*,73050688; EV10DB-*US00130*,73050805; EV10DB-*US00123*,73050806; EV10DB-*US00127*,73050807; EV10DB-*US00126*,73050808; EV10DB-*US00129*,73050809; EV10DB-*US00128*,73050810; EV10DB-*US00125*,73050812; EV10DB-*US00122*,73060000; EV10DB-*US00151*,13010484; EV10DB-*US00131*,23010651; EV10DB-*US00137*,33010608; EV10DB-*US00133*,53010863; EV10DB- *US00152*,53010928; EV10DB-*US00135*,53010929; EV10DB-*US00157*,53050630; EV10DB-*US00155*,53050631; EV10DB-*US00153*,53050632; EV10DB-*US00142*,53050865; EV10DB-*US00143*,53050866; EV10DB-*US00149*,53050867; EV10DB-*US00145*,53050868; EV10DB-*US00140*,53050869; EV10DB-*US00146*,53050870; EV10DB-*US00132*,73010716; EV10DB-*US00136*,73010765; EV10DB-*US00150*,73010824; EV10DB-*US00138*,73010825; EV10DB-*US00156*,73050441; EV10DB-*US00159*,73050443; EV10DB-*US00158*,73050444; EV10DB-*US00147*,73050680; EV10DB-*US00148*,73050681; EV10DB-*US00141*,73050682; EV10DB-*US00139*,73050683; EV10DB-*US00160*,73050442; EV10DB-*UK00150*,53010988; EV10DB-*UK00155*,53010676; EV10DB-*UK00158*,53010677; EV10DB-*UK00163*,73010884; EV10DB-*UK00173*,13010532; EV10DB-*UK00179*,53010668; EV10DB-*UK00181*,53010670; EV10DB-*UK00189*,13010530; EV10DB-*UK00192*,73010599; EV10DB-*UK00195*,53010791; EV10DB-*UK00200*,53010785; EV10DB-*UK00202*,53010789; EV10DB-*UK00203*,53010847; EV10DB-*UK00205*,73010750; EV10DB-*UK00206*,73010749; EV10DB-*UK00209*,53010787; EV10DB-*UK00220*,73010780; EV10DB-*UK00222*,53010776; EV10DB-*UK00227*,33010692; EV10DB-*UK00228*,73010691; EV10DB-*UK00230*,53010779; EV10DB-*UK00231*,73010689; EV10DB-*UK00232*,43010700; EV10DB-*UK00233*,53010788; EV10DB-*UK00236*,33010695; EV10DB-*UK00241*,13010525; EV10DB-*UK00248*,53010908; EV10DB-*UK00251*,33010620; EV10DB-*UK00252*,73010802; EV10DB-*UK00253*,53010907; EV10DB-*UK00256*,33010625; EV10DB-*UK00261*,23010532; EV10DB-*UK00265*,43010632; EV10DB-*UK00268*,73010628; EV10DB-*UK00270*,53010698; EV10DB-*UK00272*,53010688; EV10DB-*UK00276*,53010687; EV10DB-*UK00278*,23010545; EV10DB-*UK00279*,13010528; EV10DB-*UK00282*,23010533; EV10DB-*UK00286*,23010531; EV10DB-*UK00289*,73010616; EV10DB-*UK00292*,43010832; EV10DB-*UK00297*,33010838; EV10DB-*UK00298*,33010839; EV10DB-*UK00299*,43010831; EV10DB-*UK00303*,53010962; EV10DB-*UK00307*,73010859; EV10DB-*UK00309*,43010808; EV10DB-*UK00310*,43010807; EV10DB-*UK00311*,33010810; EV10DB-*UK00313*,43010811; EV10DB-*UK00315*,13010609; EV10DB-*UK00319*,43010809; EV10DB-*UK00326*,33010808; EV10DB-*UK00330*,73010858; EV10DB-*UK00341*,43010238; EV10DB-*UK00349*,53010825; EV10DB-*UK00359*,73010665; EV10DB-*UK00360*,53010738; EV10DB-*UK00361*,73010663; EV10DB-*UK00366*,73010871; EV10DB-*UK00367*,53010734; EV10DB-*UK00370*,73010776; EV10DB-*UK00376*,53010876; EV10DB-*UK00383*,43010232; EV10DB-*UK00385*,73010651; EV10DB-*UK00390*,43010602; EV10DB-*UK00398*,33010591; EV10DB-*UK00400*,33010592; EV10DB-*UK00403*,53010978; EV10DB-*UK00409*,53010722; EV10DB-*UK00411*,53010909; EV10DB-*UK00421*,23010568; EV10DB-*UK00425*,13010562; EV10DB-*UK00426*,13010563; EV10DB-*UK00429*,13010503; EV10DB-*UK00430*,73010588; EV10DB-*UK00431*,13010561; EV10DB-*UK00432*,53010914; EV10DB-*UK00433*,73010810; EV10DB-*UK00435*,53010910; EV10DB-*UK00446*,43010624; EV10DB-*UK00452*,73010754; EV10DB-*UK00461*,43010695; EV10DB-*UK00475*,53050530; EV10DB-*UK00477*,73050341; EV10DB-*UK00479*,73050344; EV10DB-*UK00487*,73050676; EV10DB-*UK00490*,43050817; EV10DB-*UK00492*,53050898; EV10DB-*UK00500*,73050732; EV10DB-*UK00501*,73050729; EV10DB-*UK00502*,73050733; EV10DB-*UK00505*,73050678; EV10DB-*UK00507*,53050915; EV10DB-*UK00510*,43050821; EV10DB-*UK00512*,53050914; EV10DB-*UK00521*,73050460; EV10DB-*UK00529*,53050677; EV10DB-*UK00560*,73050719; EV10DB-*UK00581*,53050826; EV10DB-*UK00582*,43050567; EV10DB-*UK00583*,43050806; EV10DB-*UK00595*,53050881; EV10DB-*UK00598*,73050693; EV10DB-*UK00600*,73050311; EV10DB-*UK00606*,73050696; EV10DB-*UK00613*,43050804; EV10DB-*UK00619*,73050387; EV10DB-*UK00621*,53050577; EV10DB-*UK00623*,53050576; EV10DB-*UK00627*,73050495; EV10DB-*UK00628*,53050687; EV10DB-*UK00629*,73050500; EV10DB-*UK00630*,73050497; EV10DB-*UK00636*,53050686; EV10DB-*UK00637*,73050462; EV10DB-*UK00639*,53050655; EV10DB-*UK00640*,53050618; EV10DB-*UK00643*,53050617; EV10DB-*UK00645*,73050508; EV10DB-*UK00648*,53050699; EV10DB-*UK00653*,53050654; EV10DB-*UK00655*,53050697; EV10DB-*UK00657*,53050696; EV10DB-*UK00659*,43050572; EV10DB-*UK00660*,53050653; EV10DB-*UK00661*,73050467; EV10DB-*UK00666*,73050468; EV10DB-*UK00668*,43050809; EV10DB-*UK00670*,53050906; EV10DB-*UK00671*,43050812; EV10DB-*UK00673*,73050456; EV10DB-*UK00675*,53050644; EV10DB-*UK00676*,73050455; EV10DB-*UK00678*,33050776; EV10DB-*UK00679*,53050890; EV10DB-*UK00680*,43050811; EV10DB-*UK00681*,43050813; EV10DB-*UK00683*,73050720; EV10DB-*UK00685*,53050908; EV10DB-*UK00687*,53050929; EV10DB-*UK00689*,53050579; EV10DB-*UK00691*,73050394; EV10DB-*UK00693*,53050580; EV10DB-*UK00695*,73050324; EV10DB-*UK00696*,73050392; EV10DB-*UK00698*,43050457; EV10DB-*UK00699*,53050924; EV10DB-*UK00700*,73050737; EV10DB-*UK00701*,53050926; EV10DB-*UK00702*,73050741; EV10DB-*UK00703*,53050925; EV10DB-*UK00706*,73050742; EV10DB-*UK00709*,53050646; EV10DB-*UK00712*,73050740; EV10DB-*UK00713*,53050907; EV10DB-*UK00717*,73050722; EV10DB-*UK00721*,73050381; EV10DB-*UK00723*,53050571; EV10DB-*UK00725*,43050837; EV10DB-*UK00726*,33050793; EV10DB-*UK00727*,53050922; EV10DB-*UK00730*,33050794; EV10DB-*UK00731*,33050431; EV10DB-*UK00733*,73050383; EV10DB-*UK00736*,53050611; EV10DB-*UK00737*,33050792; EV10DB-*UK00739*,73050382; EV10DB-*UK00740*,73050420; EV10DB-*UK00741*,73050323; EV10DB-*UK00742*,53050509; EV10DB-*UK00743*,73050422; EV10DB-*UK00746*,73050325; EV10DB-*UK00747*,53050508; EV10DB-*UK00748*,73050659; EV10DB-*UK00750*,53050511; EV10DB-*UK00753*,73050321; EV10DB-*UK00755*,53050612; EV10DB-*UK00756*,73050421; EV10DB-*UK00758*,73050419; EV10DB-*UK00760*,73050347; EV10DB-*UK00761*,73050346; EV10DB-*UK00762*,53050534; EV10DB-*UK00763*,73050658; EV10DB-*UK00766*,43050857; EV10DB-*UK00767*,43050432; EV10DB-*UK00768*,53050935; EV10DB-*UK00769*,43050434; EV10DB-*UK00770*,43050430; EV10DB-*UK00771*,73050652; EV10DB-*UK00773*,73050744; EV10DB-*UK00777*,53050844; EV10DB-*UK00778*,53050934; EV10DB-*UK00781*,73050384; EV10DB-*UK00782*,53050568; EV10DB-*UK00785*,53050569; EV10DB-*UK00786*,73050747; EV10DB-*UK00788*,53050536; EV10DB-*UK00789*,53050613; EV10DB-*UK00791*,73050348; EV10DB-*UK00792*,43050854; EV10DB-*UK00795*,53050837; EV10DB-*UK00797*,53050610; EV10DB-*UK00800*,73050423; EV10DB-*UK00805*,73050385; EV10DB-*UK00808*,43050433; EV10DB-*UK00809*,33050430; EV10DB-*UK00811*,53050931; EV10DB-*UK00812*,53050535; EV10DB-*UK00816*,43050856; EV10DB-*UK00817*,73050738; EV10DB-*UK00818*,53050538; EV10DB-*UK00819*,33050429;
  • 의료기기 분류등급
    Physical Medicine Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide
  • 제품 설명
    Medline Strider Midi 3 Scooter; a three wheeled battery operated scooter; manufactured by KYMCO, Kaohsiung, Taiwan for Medline Industries, Inc., One Medline Place, Mudelein, IL 60060 USA; model MDS807500 - red and MDS807500B - blue
  • Manufacturer
    Medline Industries Inc

Manufacturer

Medline Industries Inc
  • 제조사 주소
    Medline Industries Inc, 1 Medline Pl, Mundelein IL 60060-4486
  • Source
    USFDA