Device Recall Monode

  • Modelo / Serial
    Model #: 02200002  All units received from the manufacture prior to the week of July 12, 2015
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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
  • Descripción del producto
    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
  • 1 Event

Fabricante

  • Dirección del fabricante
    DJO, LLC, 1430 Decision St, Vista CA 92081-8553
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA

2 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Product Code: 833-137, Batch: 02H1103434, 02H1200349, and 02K1201354.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution -- USA, including the state of MA, and the country of Germany
  • Descripción del producto
    Monodek Violet Synthetic Absorbable Surgical Sutures, MF 0 TC43/HR26 48
  • Manufacturer
  • Modelo / Serial
    NDR, MDK VI MF 0 TC43/HR2648, Catalog #833-137, Lot #2503061, 2503063, 2761528, 2761529 2694983, 3152877, 3169994, 2395967, 3163970 & 3232258; Monodek, MDK VI MF 2-0 FS-1 1N27, Catalog # M451V, Lot #2360982 & 2381287.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide-, USA including states of CO, FL, IL, IN, MA, and OH, and Countries of Canada, France and Germany
  • Descripción del producto
    Suture Diameter/Strength specification failure: Various Polydioxanone Absorbable Surgical Sutures-NDR, MDK VI MF 0 TC43/HR2648, Catalog #833-137, Monodek, MDK VI MF 2-0 FS-1 1N27, Catalog # M451V
  • Manufacturer