Events

Retiro De Equipo (Recall) de Device Recall Handicare USA's Minivator Bath Bliss Reclining Bath Lifts (Bath Bliss), handset

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 Handicare Accessibility.

¿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
    63859
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0171-2014
  • Fecha de inicio del evento
    2012-11-29
  • Fecha de publicación del evento
    2013-11-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-12-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114924
  • 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
    Firm became aware that two handsets in the affected batches became inoperable while the user was in the tub.
  • Acción
    Handicare sent an Urgent Medical Device Recall letter dated November 29, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately advise all of their customers affected by the recall letter to immediately remove all affected product from use. Upon receipt of affected product, replacement handsets would be sent to customers. Customers with questions were instructed to call 866-276-5438 or email Customerservice.usa@handicare.com. For questions regarding this recall call 610-266-5260.

Device

Device Recall Handicare USA's Minivator Bath Bliss Reclining Bath Lifts (Bath Bliss), handset
  • Modelo / Serial
    Handsets shipped with Bath Lifts belonging to the following serial numbers: BH05100001 - BH05129999 and BH06120001 - BH11129999; Handsets shipped as spare parts with the following serial numbers: BS05100001 - BS05129999 and BS06120001 - BS11129999.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (Nationwide) and country of: Canada.
  • Descripción del producto
    Handset component of the Handicare USA's Minivator Bath Bliss Reclining Bath Lifts (Bath Bliss), Part Number BP300-100/BP300-400RSUS (handset) - Model Numbers BBR0311USAB (blue) and BBR0311USSS (silver) || Handset component devices operate the Minivator Bath Bliss Reclining Bath Lift, a non-AC-powered patient lift consisting of a motorized actuator, powered mechanical seating device, temporarily secured in a bath, and used to lift and lower a patient in the vertical or reclining position while bathing.
  • Manufacturer
    Handicare Accessibility

Manufacturer

Handicare Accessibility
  • Dirección del fabricante
    Handicare Accessibility, 2201 Hangar Place, #200, Allentown PA 18109
  • Empresa matriz del fabricante (2017)
    Handicare Group Ab
  • Source
    USFDA