Events

Retiro De Equipo (Recall) de Device Recall MPI Rapid Response HUT Table, Model RRHUT 1217

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Medical Positioning Inc.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    61348
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1210-2012
  • Fecha de inicio del evento
    2012-03-05
  • Fecha de publicación del evento
    2012-03-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-07-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107869
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Table, examination, medical, powered - Product Code LGX
  • Causa
    The warning label regarding electrical shock was not placed on the device warning to have the power switch in the "off" position prior to connecting the unit to electric power.
  • Acción
    Medical Positioning Inc. sent a "RAPID RESPONSE HUT TABLE LABELING CORRECTION NOTIFICATION" letter dated March 5, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter included an Owner's Manual insert page which clearly states the warning and how to avoid the electric shock hazard and a warning tag to attach to the product's power cord near the plug end using the provided wire tie. Contact the firm at 816-595-2356 for questions regarding this notice.

Device

Device Recall MPI Rapid Response HUT Table, Model RRHUT 1217
  • Modelo / Serial
    Serial numbers 802286, 802303, 802782, and 802722
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) including the states of IN, KS, WI, NY, IL, NC, OH, and MS and the country of Thailand.
  • Descripción del producto
    MPI Rapid Response HUT Table, Model #RRHUT 1217 with Dual 2 Way Drop Section. The firm name on the label is Medical Positioning Inc., Kansas City, MO. || Designed for multiple uses including a conventional examination table, unexplained syncope, neurocardiogenic syncope, chronic fatigue syndrome, and most noninvasive procedures. With the optional drop section, the use expands to echo/stress echo/Doppler studies, and vascular and carotid echo.
  • Manufacturer
    Medical Positioning Inc

Manufacturer

Medical Positioning Inc
  • Dirección del fabricante
    Medical Positioning Inc, 1717 Washington St, Kansas City MO 64108-1121
  • Empresa matriz del fabricante (2017)
    Medical Positioning Inc.
  • Source
    USFDA