Events

Retiro De Equipo (Recall) de Stryker Instruments Navigation System II PC SPC1 Assembly

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 Stryker Instruments Div. of Stryker 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
    53614
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0123-2010
  • Fecha de inicio del evento
    2009-10-26
  • Fecha de publicación del evento
    2009-11-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-12-31
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86039
  • 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
    Neurological Stereotaxic Instrument - Product Code HAW
  • Causa
    Multiple software-related malfunctions may occur. the device may suddenly stop working, the screen may freeze, the screen may only be updated very slowly, the unit may not respond to user input, or the unit may only respond to user very slowly.
  • Acción
    The firm issued a press release on 11/4/09. Consignees were notified by an Urgent: Medical Device Recall Notification letter dated 10/23/09, which advised of the affected products, the reason for the recall, the recall plan, and the actions to be taken. Customers were to immediately review this notification and distribute to all departments affected. Also, customers were to immediately quarantine any affected product and label as recalled product; complete and sign the enclosed Business Reply Form and fax a copy to 866-521-2762. Upon receipt of the form, a Stryker Navigation Field Service Rep would contact them to schedule the repair of their equipment. All U.S. units were corrected by 10/30/09.

Device

Stryker Instruments Navigation System II PC SPC1 Assembly
  • Modelo / Serial
    Serial number K7P00F6000.
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA, including states of Florida, Kansas, Kentucky, Massachusetts, Michigan, New Jersey, Pennsylvania, South Carolina, Texas, and Washington and countries of Australia, China, Germany, Japan, Korea, Switzerland, and the United Kingdom.
  • Descripción del producto
    Stryker Instruments Navigation System II PC SPC-1 Assembly, Stryker Navigation, Kalamazoo, MI; REF 7700-101-201. || The Stryker Navigation System II is a computer-aided surgery platform, supporting surgeons to perform surgical interventions.
  • Manufacturer
    Stryker Instruments Div. of Stryker Corporation

Manufacturer

Stryker Instruments Div. of Stryker Corporation
  • Dirección del fabricante
    Stryker Instruments Div. of Stryker Corporation, 4100 E. Milham Ave., Kalamazoo MI 49001
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    USFDA