Events

Retiro De Equipo (Recall) de Device Recall EncompassTSS

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 Encompass Therapeutic Support Systems dba BG North America.

¿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
    55074
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1216-2010
  • Fecha de inicio del evento
    2010-03-05
  • Fecha de publicación del evento
    2010-03-31
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-03-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89827
  • 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
    AccuMax Quantum Pressure relief systems - Product Code FNM
  • Causa
    Potential out gasing of the battery and short term ignition of the gas within the control unit enclosure. this failure mode includes a risk for fire.
  • Acción
    An "URGENT RECALL NOTIFICATION" letter dated March 5, 2010, was sent to the customers. The letter describes the product, problem and action to be taken by the customers. The customers should immediately discontinue use of the control unit, turn off the unit and disconnect from the wall socket and quarantine the unit away from any patient's room. The customers should immediately examine your inventory and quarantine the products listed; identify and notify any facility where they may have further distributed or transferred the listed products; and complete and return the REPLY/FAX-BACK FORM as soon as possible to Fax: (626) 796-7856 or mail to EncompassTSS, 100 E. Corson Street, Ste 310, Pasadena, CA 91103. Please contact EncompassTSS Customer Service at 800-822-8288 if you have any questions regarding this recall notice.

Device

Device Recall EncompassTSS
  • Modelo / Serial
    Serial No: 6101, 6170 and 6267-6613
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution: CA, TX, IN, OR, and MO.
  • Descripción del producto
    AccuMax Quantum Complete (Model CU3/CU4), an alternating pressure with turn assist & on demand low air loss system; Encompass Therapuetic Support Systems, Glendale, CA. || The device is intended to treat or prevent decubitus ulcers, extensive burns, urinary tract blockage and to aid circulation.
  • Manufacturer
    Encompass Therapeutic Support Systems dba BG North America

Manufacturer

Encompass Therapeutic Support Systems dba BG North America
  • Dirección del fabricante
    Encompass Therapeutic Support Systems dba BG North America, 500 N Central Ave Ste 900, Glendale CA 91203-3346
  • Source
    USFDA