Retiro De Equipo (Recall) de Device Recall HillRom Affinity Four Birthing Bed

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
    53987
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0548-2010
  • Fecha de inicio del evento
    2009-11-16
  • Fecha de publicación del evento
    2009-12-17
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2012-07-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • 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
    Table, obstetrical, ac-powered (and accessories) - Product Code HDD
  • Causa
    The brakes may not hold or lock.
  • Acción
    Hill-Rom issued an "Urgent Safety Notice" notification dated November 16, 2009 to customers. The letter advised users of the problem and asking them to locate the beds and to remove them from use until corrected if possible and, if not possible to inspect them for the problem and remove them from use if it is present. The firm will visit each account to make corrections. For further information, contact Hill-Rom Technical Support at 1-800-445-3720.

Device

  • Modelo / Serial
    All beds distributed between 11/27/06 and 6/18/08. Serial Numbers: H299AA4675, H299AA4676, H299AA4679, H299AA4681, H331AA4786, H331AA4787, H331AA4788, H332AA4789, H332AA4790, H332AA4791, H332AA4792, H332AA4793, H332AA4794, H332AA4795, H333AA4796, H333AA4797, H333AA4798, H333AA4799, H333AA4800, H333AA4802, H334AA4803, H334AA4804, H334AA4805, H334AA4807, H334AA4808, H334AA4809, H334AA4810, H335AA4801, H335AA4811, H335AA4812, H335AA4813, H335AA4814, H338AA4822, H338AA4823, H338AA4824, H338AA4825, H338AA4826, H338AA4829, H339AA4831, H339AA4832, H339AA4833, H339AA4835, H339AA4836, H339AA4837, H339AA4838, H339AA4839, H339AA4840, H340AA4841, H340AA4842, H340AA4843, H340AA4844, H340AA4845, H340AA4846, H340AA4849, H340AA4850, H340AA4851, H340AA4852, H341AA4853, H341AA4854, H341AA4855, H341AA4856, H341AA4857, H341AA4860, H341AA4861, H342AA4862, H342AA4863, H342AA4864, H342AA4865, H342AA4868, H342AA4870, H345AA4874, H345AA4875, H345AA4876, H345AA4877, H345AA4879, H345AA4880, H345AA4881, H346AA4883, H346AA4884, H346AA4887, H346AA4889, H347AA4891, 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  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- United States, Canada, Argentina, Australia, Bahamas, Brazil, Chile, China, Denmark, Dominican Republic, France, Great Britain, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Kuwait, Libiya, Netherlands, Poland, Puerto Rico, Russia, Saudi Arabia, Serbia, Singapore, Spain, Sweden, Syria, Thailand, Turkey and United Arab Emirates.
  • Descripción del producto
    Hill-Rom Affinity Four Birthing Bed, Hill-Rom Company, Inc., Batesville, Indiana; Model P3700B. || Intended to be used as birthing beds for momen of child bearing age in an labor, delivery, recovery or postpartum setting in acute care.
  • Manufacturer

Manufacturer

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