Events

Retiro De Equipo (Recall) de Device Recall RotoRest Delta Kinetic Therapy System

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 KCI USA, 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
    62805
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0409-2013
  • Fecha de inicio del evento
    2012-06-27
  • Fecha de publicación del evento
    2012-11-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-04-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111749
  • 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
    Bed, flotation therapy, powered - Product Code IOQ
  • Causa
    The firm is initiating a voluntary medical device correction for the rotorest delta therapy system head pack. kci has received complaints alleging patients experiencing skin breakdown on the head and face due to the positioning of the head pack. in a few instances, the patient received injuries ranging from stage iii to stage iv pressure ulcers.
  • Acción
    KCI sent an Urgent - Voluntary Medical Device Correction letter dated June 27, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed that KCI would contact them soon to coorinate a shipment of a replacement of the affected product. For any questions customers were instructed to call 1-800-275-4524, Selection Option 3 followed by Option 2. For questions regarding this recall call 1-800-275-4524.

Device

Device Recall RotoRest Delta Kinetic Therapy System
  • Modelo / Serial
    Model Number 208030, Serial Numbers: 00157087, 00157091, 00157288, 00157375, 00157405, RRCKOO011, RRHKOO065, RRHKOO074, RRHKOO096, RRHK00109, and RRHKOO117.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including AL, CA, CO, OK and GA.
  • Descripción del producto
    RotoRest Delta Kinetic Therapy System || INDICATIONS: Treatment and prevention of pulmonary complications as a result of immobility, Thoracic or lumbar fracture, Cervical traction, Skeletal traction
  • Manufacturer
    KCI USA, Inc.

Manufacturer

KCI USA, Inc.
  • Dirección del fabricante
    KCI USA, Inc., 4958 Stout Dr, San Antonio TX 78219-4334
  • Source
    USFDA