Events

Retiro De Equipo (Recall) de Device Recall SmartMonitor 2 PS/PSL

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 Circadiance 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
    77176
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2250-2017
  • Fecha de inicio del evento
    2017-05-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-02-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155172
  • 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
    Material, embolization, neurovascular, polymerizing or precipitating - Product Code NPE
  • Causa
    Circadiance has determined that it is possible for certain smart monitor 2ps/psl monitors to exhibit intermittent operation of the nurse call feature. the firm has updated the device to increase the "nurse call" feature to ensure monitor alarms are transmitted to compatible nurse call systems.
  • Acción
    Circadiance mailed a Medical Device Removal SmartMonitor 2 PS/PSL, dated 04/28/2017, to affected customers to inform them of the issue, the actions to be taken and the actions the firm plans to take to correct the issue. Customers are told to test the functionality of the system prior to each use; and, complete the Business Reply Form. The form can be returned via 412-202-4583 or emailed to james.gianoutsos@circadiance.com. Customers are to contact Circadiance Customer Service at 724-858-2837 to receive an Return Material Authorization number; or, 1-888-825-9640 to repair their unit free of charge, or for questions or support.

Device

Device Recall SmartMonitor 2 PS/PSL
  • Modelo / Serial
    Unique Device Identifier (UDI) 1030271, 1038140, 1038141, U1030271, and U1038140.  All serial numbers of units with "REF", "MODEL" or standalone part number 1030271, 1038140, 1038141, U1030271 or U1038140 located on the products label are impacted by this notice. Monitors with the above part numbers that have a serial number starting with "CP" are NOT affected by this issue.
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    SmartMonitor 2 PS/PSL, Monitor, Apnea, Facility USE. || Intended for use in the continuous monitoring of respiration, heart rate, and SP02 of infant, pediatric and adult patients.
  • Manufacturer
    Circadiance LLC

Manufacturer

Circadiance LLC
  • Dirección del fabricante
    Circadiance LLC, 1060 Corporate Ln, Export PA 15632-8905
  • Empresa matriz del fabricante (2017)
    Circadiance LLC
  • Source
    USFDA