Events

Retiro De Equipo (Recall) de Overhead Rail 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 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
    62334
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0872-2013
  • Fecha de inicio del evento
    2012-10-31
  • Fecha de publicación del evento
    2013-02-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-03-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110244
  • 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
    Lift, patient, non-ac-powered - Product Code FSA
  • Causa
    Liko/hill-rom to date has received two reports from facilities alleging that the overhead rail system has failed to the extent that the overhead rails have fallen down while in use in high humidity (swimming pool) areas. analysis of the incidents suggest that the components (hardware) used to secure the rail to the ceiling had corroded and may be unsuitable for environments with an atmosphere con.
  • Acción
    Liko, a Hill-Rom company, sent an URGENT MEDICAL DEVICE RECALL notice dated October 31, 2012 to all affected customers. Letter identified the affected product, problem and actions to be taken until a new design is finalized and the field corrective action implemented. The letter instructed customers to complete and return the Response Form immediately even if you do not have any rail systems in a chlorinated environment. For questions concerning this request or the procedure as outlined, please contact Hill-Rom Technical Support at 800-445-3720.

Device

Overhead Rail System
  • Modelo / Serial
    The Liko Overhead Rail System components are not serialized and have been distributed since the early 1980's to the present.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: USA (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY; and CANADA LOCATIONS: AB, BC, MB, NB, NS, ON, and SK.
  • Descripción del producto
    Liko Overhead Rail System, Ceiling Mounted Rail Systems for all Liko Stationary Lifts including Likorall, Multirall and Masterlift Systems || Product Usage - The Overhead Rail System allows overhead lifts to be mounted to the ceiling allowing versatility for use in lifting situations. It can be used with different Liko ceiling lifts.
  • 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