Events

Rappel de Device Recall Monode

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 DJO, LLC.

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
    72168
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0121-2016
  • Date de mise en oeuvre de l'événement
    2015-08-21
  • Date de publication de l'événement
    2015-10-15
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-10-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140080
  • 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
    Diathermy, shortwave, for use in applying therapeutic deep heat - Product Code IMJ
  • Cause
    Overheating and burning of the wire insulation inside the applicator.
  • Action
    The firm sent out two customer notification letters; one to distributors and one to direct users. Letters were sent September 1, 2015 via USPS certified return receipt. Distributors were asked to obtain a list of their customers with contact information that have purchase or received the monode accessory or Intelect Shortwave device that included the monode as an accessory item. Once the list has been assembled the firm requests that it be forwarded to DJO Global Chattanooga Product Support by phone 877-733-4888, or by e-mail at monode.support@djoglobal.com. The firm's notification states that customers will be sent an upgraded monode accessory along with a pre-paid shipper for the return of the current used unit. Any questions the letter states to contact Product Support per the contact information above or William Fisher, Global Regulatory Compliance at 760-734-3126. Letters sent to direct users received the same instruction of returning the product for a replacement. Any questions the letter states to call 877-733-4888 or email at monode.support@djoglobal.com.

Device

Device Recall Monode
  • Modèle / numéro de série
    Model #: 02200002  All units received from the manufacture prior to the week of July 12, 2015
  • Classification du dispositif
    Physical Medicine Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the states of WY, OH, WA, NC, FL, NE, GA, KS CA, MO, IN, MA, IL, OK, AZ, TX, AR, UT, NJ, WI, PA, SC, WV, NY, MI, MN, VA, AK, TN, OR, NC, NH, KY, CO, NV, ID and the countries of El Salvador, China, Ecuador, South Korea, Chile, Israel, Peru, Nicaragua, Bolivia, Indonesia
  • Description du dispositif
    Monode, Shortwave Accessory || Model #: 02200002 || Used in conjunction with the Intelect Shortwave Diathermy 100 and Intelect Shortwave Diathermy 400 units. For the clinical application of electromagnetic energy in the radio frequency of 27.12 megahertz to generate deep heat within body tissues.
  • Manufacturer
    DJO, LLC

Manufacturer

DJO, LLC
  • Adresse du fabricant
    DJO, LLC, 1430 Decision St, Vista CA 92081-8553
  • Société-mère du fabricant (2017)
    The Blackstone Group LP
  • Source
    USFDA