Events

Retiro De Equipo (Recall) de Device Recall "Shower Helper" and "Bath Helper"

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 The Sisus Corporation.

¿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
    38096
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1172-2007
  • Fecha de inicio del evento
    2007-06-01
  • Fecha de publicación del evento
    2007-08-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-08-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=52939
  • 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
    Patient Lifts - Product Code FSA
  • Causa
    Poor welding may cause the device(s) to fail, which may result in the user, falling in the bathroom and/or a lack of assistance with bathing or toileting.
  • Acción
    On 6/8/2007, a letter was sent to all dealers and each direct account customer/user followed by a phone call to ensure the notification letter was received. Customers were instructed to discontinue use of the devices pending receipt of modification kits/ instructions to be shipped priority overnight. The firm plans to call customers/dealers to support them with the installations and ensure smooth implementation. Dealers were instructed to conduct recall to the user level.

Device

Device Recall "Shower Helper" and "Bath Helper"
  • Modelo / Serial
    The "Shower Helper" may be identified as Model SBH10.0 or as "Sisus All In One". The "Bath Helper" is identified as Model SBB10.0.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including states of PA, TX, NY, MI, AL, FL, CA, OH, CT, WA, MD, OR, NC, NH, VT, IL, CO, HI, LA, GA, TN, OK, MA, KS, SC, ME, GA, MN, IN, and DE.
  • Descripción del producto
    Non-AC-powererd Patient Lifts for assisting patients when bathing and toileting-sold under names "Bath Helper" and "Shower Helper" , Sisus Corporation, Santa Cruz, CA 95062.
  • Manufacturer
    The Sisus Corporation

Manufacturer

The Sisus Corporation
  • Dirección del fabricante
    The Sisus Corporation, 721 30th Ave, Santa Cruz CA 95062-5070
  • Source
    USFDA