Events

Rappel de Device Recall Medline Strider Midi 4 Scooter

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Medline Industries Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    36171
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-1523-06
  • Date de mise en oeuvre de l'événement
    2006-07-20
  • Date de publication de l'événement
    2006-09-23
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2009-09-02
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48123
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    scooter - Product Code INI
  • Cause
    The p&g; solo 60a electronic control unit on the midi scooters may overheat.
  • Action
    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Midi 4 scooters have an older version of the electronic control unit that may overheat, which Medline will replace with a newer version of the controller.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 4 Scooter
  • Modèle / numéro de série
    model MDS807550 - red and model MDS807550B - blue, Scooter no., controller no.:EV10DA-*US00108*,23010640; EV10DA-*US00113*,33010241; EV10DA-*US00121*,33010242; EV10DA-*US00127*,33010243; EV10DA-*US00117*,33010244; EV10DA-*US00112*,33010245; EV10DA-*US00129*,33010806; EV10DA-*US00123*,43010239; EV10DA-*US00119*,43010240; EV10DA-*US00118*,43010241; EV10DA-*US00120*,43010242; EV10DA-*US00116*,43010243; EV10DA-*US00128*,43010813; EV10DA-*US00125*,53010812; EV10DA-*US00122*,53010813; EV10DA-*US00130*,53011070; EV10DA-*US00148*,53050909; EV10DA-*US00152*,53050910; EV10DA-*US00155*,53050911; EV10DA-*US00146*,53050912; EV10DA-*US00153*,53050913; EV10DA-*US00110*,53050937; EV10DA-*US00101*,53050938; EV10DA-*US00126*,73010717; EV10DA-*US00147*,73050724; EV10DA-*US00150*,73050725; EV10DA-*US00145*,73050726; EV10DA-*US00149*,73050727; EV10DA-*US00151*,73050728; EV10DA-*US00103*,73050748; EV10DA-*US00109*,73050749; EV10DA-*US00136*,73050750; EV10DA-*US00102*,73050786; EV10DA-*US00106*,73050787; EV10DA-*US00107*,73050788; EV10DA-*US00111*,73050789; EV10DA-*US00115*,73050790; EV10DA-*US00105*,73050791; EV10DA-*US00135*,73050792; EV10DA-*US00137*,73050793; EV10DA-*US00139*,73050794; EV10DA-*US00141*,73050795; EV10DA-*US00142*,73050796; EV10DA-*US00138*,73050797; EV10DA-*US00143*,73050798; EV10DA-*US00133*,73050799; EV10DA-*US00140*,73050800; EV10DA-*US00132*,73050811; EV10DA-*US00131*,73060001; EV10DA-*US00160*,43010614; EV10DA-*US00159*,53010814; EV10DA-*US00157*,53010866; EV10DA-*US00158*,53011075; EV10DA-*US00156*,73010768; EV10DA-*US00162*,33010606; EV10DA-*US00165*,43010805; EV10DA-*US00163*,53010637; EV10DA-*US00167*,D49840/3 73010564; EV10DA-*US00221*,13010485; EV10DA-*US00225*,23010490; EV10DA-*US00223*,53010638; EV10DA-*US00222*,73010565; EV10DA-*UK00221*,43010782; EV10DA-*UK00227*,43010736; EV10DA-*UK00228*,43010733; EV10DA-*UK00232*,33010755; EV10DA-*UK00236*,33010797; EV10DA-*UK00240*,53011045; EV10DA-*UK00242*,73010819; EV10DA-*UK00248*,13010491; EV10DA-*UK00249*,53010926; EV10DA-*UK00257*,53010925; EV10DA-*UK00260*,53010923; EV10DA-*UK00266*,53010927; EV10DA-*UK00269*,53010830; EV10DA-*UK00271*,43010586; EV10DA-*UK00272*,53010829; EV10DA-*UK00275*,33010573; EV10DA-*UK00292*,53010861; EV10DA-*UK00310*,53011092; EV10DA-*UK00311*,53011085; EV10DA-*UK00315*,33020062; EV10DA-*UK00320*,53020055; EV10DA-*UK00321*,73010881; EV10DA-*UK00325*,73010563; EV10DA-*UK00336*,23010487; EV10DA-*UK00339*,13010481; EV10DA-*UK00345*,73010684; EV10DA-*UK00353*,73010688; EV10DA-*UK00357*,53010784; EV10DA-*UK00370*,53010634; EV10DA-*UK00373*,53010904; EV10DA-*UK00381*,43010587; EV10DA-*UK00383*,33010645; EV10DA-*UK00385*,73010798; EV10DA-*UK00409*,33010676; EV10DA-*UK00416*,43010680; EV10DA-*UK00420*,33010643; EV10DA-*UK00428*,73010703; EV10DA-*UK00432*,73010702; EV10DA-*UK00435*,53010844; EV10DA-*UK00448*,53010870; EV10DA-*UK00449*,13010496; EV10DA-*UK00459*,73010922; EV10DA-*UK00729*,53010726; EV10DA-*UK00733*,43010644; EV10DA-*UK00737*,43010648; EV10DA-*UK00748*,33010639; EV10DA-*UK00777*,43010692; EV10DA-*UK01382*,53050664; EV10DA-*UK01421*,43050439; EV10DA-*UK01516*,43050568; EV10DA-*UK01567*,73050340; EV10DA-*UK01570*,53050749; EV10DA-*UK01580*,33050609; EV10DA-*UK01582*,53050748; EV10DA-*UK01583*,73050568; EV10DA-*UK01589*,53050757; EV10DA-*UK01590*,73050563; EV10DA-*UK01593*,73050566; EV10DA-*UK01595*,43050625; EV10DA-*UK01599*,53050758; EV10DA-*UK01601*,43050624; EV10DA-*UK01603*,73050576; EV10DA-*UK01611*,33050640; EV10DA-*UK01612*,73050501; EV10DA-*UK01616*,33050638; EV10DA-*UK01626*,43050639; EV10DA-*UK01640*,43050427; EV10DA-*UK01641*,73050376; EV10DA-*UK01645*,53050545; EV10DA-*UK01651*,33050437; EV10DA-*UK01652*,33050425; EV10DA-*UK01656*,73050379; EV10DA-*UK01657*,53050544; EV10DA-*UK01658*,43050438; EV10DA-*UK01661*,53050566; EV10DA-*UK01662*,73050356; EV10DA-*UK01665*,33050426; EV10DA-*UK01666*,73050377; EV10DA-*UK01669*,53050659; EV10DA-*UK01672*,73050309; EV10DA-*UK01673*,33050642; EV10DA-*UK01679*,73050471; EV10DA-*UK01680*,53050661; EV10DA-*UK01683*,73050308; EV10DA-*UK01686*,33050625; EV10DA-*UK01687*,73050472; EV10DA-*UK01688*,53050495; EV10DA-*UK01689*,73050307; EV10DA-*UK01690*,53050494; EV10DA-*UK01695*,73050306; EV10DA-*UK01700*,73050310; EV10DA-*UK01701*,73050579; EV10DA-*UK01703*,53050820; EV10DA-*UK01708*,53050761; EV10DA-*UK01711*,53050786; EV10DA-*UK01713*,73050492; EV10DA-*UK01716*,53050679; EV10DA-*UK01719*,53050764; EV10DA-*UK01721*,53050668; EV10DA-*UK01722*,43050635; EV10DA-*UK01745*,53050787; EV10DA-*UK01763*,43050840; EV10DA-*UK01766*,33050796; EV10DA-*UK01770*,33050773; EV10DA-*UK01776*,53050887; EV10DA-*UK01778*,53050884; EV10DA-*UK01779*,73050734; UK01421, D50574.02 AU04101795
  • Classification du dispositif
    Physical Medicine Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide
  • Description du dispositif
    Medline Strider Midi 4 Scooter; a four wheeled battery operated scooter; manufactured by KYMCO, Kaohsiung, Taiwan for Medline Industries, Inc., One Medline Place, Mudelein, IL 60060 USA; model MDS807550 - red and MDS807550B - blue
  • Manufacturer
    Medline Industries Inc

Manufacturer

Medline Industries Inc
  • Adresse du fabricant
    Medline Industries Inc, 1 Medline Pl, Mundelein IL 60060-4486
  • Source
    USFDA