Events

Retiro De Equipo (Recall) de Device Recall Ceegraph/Sleepscan Netlink with Video

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 Bio-Logic Systems Corp.

¿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
    38473
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0001-2008
  • Fecha de inicio del evento
    2007-07-26
  • Fecha de publicación del evento
    2007-11-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-08-12
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53825
  • 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
    Electroencephalograph - Product Code GWQ
  • Causa
    Bio-logic system corp camera pole may weaken and detach at the base of the telescoping camera pole during transport causing pole to break at the welded base and fall.
  • Acción
    Bio-logic sent a Safety Alert letters dated 7/26/07 to the affected customers, warning them that using the pole to transport the cart may cause the weld at the base of the pole to weaken, causing it to break. As a precaution to ensure customer safety, the accounts were instructed to place the enclosed red sticker on the pole, below the tightening knob. An Instruction sheet is enclosed . The warning label reads: "Caution: Do not use as a handle to move cart. Always lower camera when transporting. Avoid sudden stops or collisions." The accounts were requested to complete and return an enclosed reply sheet acknowledging the receipt of the letter and the placement of the warning labels on the poles. Any questions were directed to Customer Support at 1-800-332-3114.

Device

Device Recall Ceegraph/Sleepscan Netlink with Video
  • Modelo / Serial
    Pole assembly 580-VIDPOL and 585-CYBPSM, used with Models 580-IPCART and 580-PNCART - the cart component of the Ceegraph/Sleepscan Netlink with Video. There are no serial numbers on the pole assembly.
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA and China, Egypt, Hong Kong, Israel, Malaysia and Saudi Arabia
  • Descripción del producto
    Bio-logic System Corp --Telescoping Camera Pole Assembly (part number 585-CYBPSM and 580-VIDPOL) and assemblies (580IPCART and 580 PNCART; Bio-Logic Systems Corporation, Mundelein, IL 60060; The Model 580-VIDPOL is used with the 580-PNCART that is wired for use with a Panasonic Camera. The pole is also a subassembly of the 585-CYBPSM with wires used in the 580-IPCART wired for the use with an Ipela Camera. Both carts are a component of the Ceegraph/Sleepscan Netlink with Video.
  • Manufacturer
    Bio-Logic Systems Corp

Manufacturer

Bio-Logic Systems Corp
  • Dirección del fabricante
    Bio-Logic Systems Corp, 1 Bio Logic Plaza, Mundelein IL 60060-3708
  • Source
    USFDA