Events

Retiro De Equipo (Recall) de Device Recall Rapid Response HUT Table

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
    58035
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1973-2011
  • Fecha de inicio del evento
    2010-02-01
  • Fecha de publicación del evento
    2011-04-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-06-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98053
  • 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
    Tilting Radiologic Table - Product Code IXR
  • Causa
    The tilt tables work intermittently and some have become stuck in an inclined or reclined position during procedures.
  • Acción
    An undated Urgent - Voluntary Medical Device Product Correction letter was issued on 2/1/2010 by certified mail with return receipt requested. The letter identified the model and serial numbers of the affected product. The consignees were advised to stop using the table immediately and remove it from service until further notice. Customers were to contact Mr. Joe Hurtig at 1-800-593-3246 or jhurtig@medicalpositioning.com to confirm receipt of the notice and to provide the firm with the correct contact information. Individualized correction packages including replacement parts and instructions were sent to each consignee. The instructions consisted of (1) Rapid Response HUT Motor Replacement Instructions; (2) Control Box Replacement Instructions; and (3) ILD External Power Supply Removal Instructions.

Device

Device Recall Rapid Response HUT Table
  • Modelo / Serial
    598959, 599042, 599084, 599091, 599144, 599189, 599225, 599278, 599539, 599593, 599616, 599704, 599706, 599708, 599744, 599847, 599862, 599937, 600018, 600032, 600046, 600106, 600107, 600343, 600428, and 600667 located on the side of the table
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA, including Puerto Rico, and Canada.
  • Descripción del producto
    Rapid Response H.U.T. (Head Up Tilt) Table. Model 1017. Powered electrophysiology tilt table. Table can tilt -15 degrees to 90 degrees (Trendelenburg). Medical Positioning Incorporated.800-593-3246. || Used in clinical and hospital settings by trained radiologists.
  • 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