Events

Retiro De Equipo (Recall) de Device Recall Clinitron Rite Hite Bed headboard and foot side rails.

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 Hill-Rom, 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
    60888
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1132-2012
  • Fecha de inicio del evento
    2012-02-03
  • Fecha de publicación del evento
    2012-03-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-12-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106718
  • 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, air fluidized - Product Code INX
  • Causa
    The firm identified in october 2011 that the clinitron rite hite bed and clinitron at home bed headboards failed to meet the safety standard force requirements. the firm identified in october 2011 that the clinitron rite hite bed and clinitron at home bed outer rail, which is extruded aluminum tubing, is intended to be one piece joined together by a weld at the lower center. the parts receiv.
  • Acción
    Hill-Rom, Inc. sent a Modification Notice Urgent Medical Device Correction Notification dated February 2, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The modification notice instructed all customers to find and replace all headboards and food side rails that do not meet design intent. All technicians will inspect all affected product in the service centers and all at home and rite hite beds for an "x" or "L" stamp. The technicians will inspect the beds that are still in use during scheduled maintenance or before each rental. All will be completed before 01-JUL-12. For support call 1-800-445-3720

Device

Device Recall Clinitron Rite Hite Bed headboard and foot side rails.
  • Modelo / Serial
    The headboard (p/n 6020200003) and siderail (p/n 6020200002) are not serialized. There are no model, catalog or code number identification marks available on the accessories. It is possible to identify these accessories though by a mark stamped into the mounting post that are used to attach these accessories to the bed. May 2011 and October 2011 headboards and siderails were shipped to customers.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA (nationwide) including the states of AL, AK, AZ, AR, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI, WV, and WY. and the country of Canada.
  • Descripción del producto
    Clinitron Rite Hite Bed headboard and foot side rails. || The Clinitron Rite Hite Air Fluidized Therapy Unit is a patient management system that combines air fluidized therapy and low airloss therapy technologies together on a low-height frame. The lower body section provides air fluidized therapy, and the upper body section provides low airloss therapy.
  • Manufacturer
    Hill-Rom, Inc.

Manufacturer

Hill-Rom, Inc.
  • Dirección del fabricante
    Hill-Rom, Inc., 1069 State Route 46 East, Batesville IN 47006-7520
  • Empresa matriz del fabricante (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA