Events

Retiro De Equipo (Recall) de Device Recall QuietCare

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 Intel-GE Care Innovations LLC.

¿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
    61719
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1615-2012
  • Fecha de inicio del evento
    2011-07-30
  • Fecha de publicación del evento
    2012-05-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-05-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108783
  • 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
    System, environmental control, powered - Product Code IQA
  • Causa
    The quietcare production system experienced a partial outage on 7/29/11. as a result of the partial outage, some monitoring data about residents' movements was not processed in the production system, and alerts were therefore not sent to caregivers. the problem was identified and corrected and the unprocessed data was recovered and processed. however, because of the time lag in processing, a fe.
  • Acción
    Initial notification to the affected facilities was done by telephone or email on 7/30/11. This was followed up with Urgent Field Notification letters to the customers on 8/12/11 via e-mail. For questions, customers were instructed to contact Customer Support at 1 (866) 772-8243.

Device

Device Recall QuietCare
  • Modelo / Serial
    Affected Serial Numbers: liqc.018778, liqc.020447, liqc.020428, liqc.024472, liqc.027039, liqc.024195, liqc.026718, liqc.023495, liqc.027065, liqc.024252, liqc.018722, liqc.024377, liqc.019808, liqc.017029, liqc.017310, liqc.026701, liqc.024190, liqc.019075, liqc.027351, liqc.023253, liqc.019497, liqc.019215, liqc.019217, liqc.017965, liqc.020530, liqc.024293, liqc.021530, liqc.026353, liqc.017900, liqc.019915, liqc.018447, liqc.021086, liqc.027072, liqc.023241, liqc.018169, liqc.017876, liqc.022049, liqc.026409, liqc.018126, liqc.019519,  liqc.017579, liqc.018271, liqc.017531, liqc.017532, liqc.018255, liqc.023888,  liqc.023340, liqc.023343, liqc.023342, liqc.018534, liqc.018536, liqc.018256,  liqc.017532, liqc.019582, liqc.021064, liqc.020981, liqc.021944, liqc.021764,  liqc.021284, liqc.017741, liqc.017738, liqc.024298, liqc.026760, liqc.027063, liqc.022321, liqc.022320, liqc.020843, liqc.022009, liqc.026620, liqc.026643,  liqc.026456, liqc.021428, liqc.021402, liqc.022054, liqc.019577, liqc.023782, liqc.023710, liqc.023708, liqc.019360, liqc.017682, liqc.021670, liqc.022983 (UK), liqc.022846 (UK).
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution - USA and the United Kingdom.
  • Descripción del producto
    QuietCare, Model Numbers QC200403, v.02; QC200403, v.03; QC200403, v.04; QC200405 (USA) and QCE200403, v.02; QCE200403, v.03 (UK). Manufacturer Living Independently Group, Inc., New York, NY. QuietCare is intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community.
  • Manufacturer
    Intel-GE Care Innovations LLC

Manufacturer

Intel-GE Care Innovations LLC
  • Dirección del fabricante
    Intel-GE Care Innovations LLC, 3721 Douglas Blvd Ste 100, Roseville CA 95661-4243
  • Source
    USFDA