Events

Rappel de Device Recall MUX100, MUX100H Xray System

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 Shimadzu Medical Systems.

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
    67353
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1150-2014
  • Date de mise en oeuvre de l'événement
    2013-11-15
  • Date de publication de l'événement
    2014-03-07
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-06-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125317
  • 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
    System, x-ray, mobile - Product Code IZL
  • Cause
    Shimadzu corporation is recalling the shimadzu mobile x-ray sytems (mux-100 and mux-100h) because the connecting metal plate which connects the main chassis and the column of mux-100 may crack.
  • Action
    A Field Safety Notice and an Urgent Voluntary Medical Device Recall Notice were sent to customers to inform them that SHIMADZU CORPORATION has identified a potential issue in certain manufacturing lots of the Shimadzu Mobile X-ray Systems. Customers are informed that as a result of their investigation, it has been learned that the connecting work of very few column used in specific lots for the MUX series was not done correctly, and it may cause a crack. Therefore, if the machine is continuously used in that condition, there is the possibility that the column will start to lean. The notices informs the customers of the actions to be taken. Customers are instructed to contact Shimadzu Medical Systems National Technical Support at (800) 228-1429.

Device

Device Recall MUX100, MUX100H Xray System
  • Modèle / numéro de série
    Serial No.  0262P70907 0262P70908 0262P70909 0262P70910 0262P71001 0262P71002 0262P71003 0262P71004 0262P71005 0262P71006 0162Z01901 0162Z01902 0162Z01903 0162Z01904 0162Z01905 0162Z02002 0162Z02003 0162Z02004 0162Z02005 0162Z02006 0162Z02007 0162Z02008 0162Z02009 0162Z02101 0162Z02108 0162Z02204 0162Z02205 0162Z02302 0162Z02303 0162Z02304 0162Z02305 0162Z02306 0162Z02307 0162Z02308 0162Z02309 0162Z02310 0262Z00205 0262Z00206 0262Z00207 0262Z00208 0262Z00209 0262Z00210 0262Z00307 0262Z00308 0262Z00309 0262Z00310 0262Z00401 0262Z00402 0262Z00403 0262Z00404 0262Z00610 0262Z00701 0262Z00702 0262Z00703 0262Z00704 0262Z00705
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    USA Nationwide Distribution
  • Description du dispositif
    Mobile X-ray System, Model: MUX-100, MUX-100H || Product Usage: || The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannnot move and/or of outpatients in emergency
  • Manufacturer
    Shimadzu Medical Systems

Manufacturer

Shimadzu Medical Systems
  • Adresse du fabricant
    Shimadzu Medical Systems, 20101 S Vermont Ave, Torrance CA 90502-1328
  • Société-mère du fabricant (2017)
    Shimadzu Corp.
  • Source
    USFDA