Events

Retiro De Equipo (Recall) de SwitchPoint Infinity 2 (SPI2) and SwitchPoint Element (SPE)

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 Communications 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
    55624
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1803-2010
  • Fecha de inicio del evento
    2010-04-30
  • Fecha de publicación del evento
    2010-06-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-04-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91362
  • 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
    Laparoscope, general & plastic surgery - Product Code GCJ
  • Causa
    Users may experience issues with the functionality of the switchpoint infinity 2 and switchpoint element that may be exhibited as a "page not found" error message, missing drop down options, or a frozen touch panel.
  • Acción
    The firm, Stryker, sent an "URGENT: Medical Device Correction" letter dated May 4, 2010, to all customers. The letter describes the product, problem and action to be taken by the customers. The firm recommended that the customer continue to use their SwitchPoint Infinity 2 or SwitchPoint Element. The customer is instructed to refer to their user manual, in the event they experience any failures; drive on module failure and/or product failure during a procedure. A Stryker representative will contact the customers facility to coordinate a service event to replace the existing component with a new component at no cost. Should the customer experience any of the aforementioned failures and require urgent technical support, please call Stryker Technical Support at 1-866-841-5663. If you have any questions regarding this letter or the implementation of this correction, please contact Shanta McKinzie at (972) 410-7319 or via email at StrykerCommunicationsRA@stryker.com.

Device

SwitchPoint Infinity 2 (SPI2) and SwitchPoint Element (SPE)
  • Modelo / Serial
    Product/Catalog Numbers: 0100224307 (SPI2 128 MB DOM Card and 0100224592 (SPE DOM Card) Lot Code: All units distributed between 14 AUG 07 and 23 MAR 09
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA and countries of Australia, EMEA, Canada, China, S. Africa, India, Japan, Latin America, Korea, Mexico, New Zealand, Taiwan, and Signapore.
  • Descripción del producto
    The SwitchPoint Infinity 2 (SPI2) and SwitchPoint Element (SPE), an integrated voice, video, data router and teleconferencing interface for the operating room. || The SwitchPoint Infinity 2 (SPI2) and SwitchPoint Element (SPE) are designed as an integrated voice, video, data router and teleconferencing interface for the operating room. The primary intent of the SPI2 and SPE product lines is to allow operating room personnel a center point for controlling all equipment and communication during surgery. The SPI2 and SPE route surgical and non-surgical images throughout the operating room to facilitate operating procedures. All video inputs and video outputs of the router require the use of various signal and cables types. Digital and analog video signals transmit from the auxiliary devices in the room through the SPI2 and SPE router to designated monitors. The primary difference between the SPI2 and SPE systems is that the SPE is a more compact version of the SPI2 offering less video inputs and outputs, and is intended to be used in smaller clinics.
  • Manufacturer
    Stryker Communications Corp

Manufacturer

Stryker Communications Corp
  • Dirección del fabricante
    Stryker Communications Corp, 1410 Lakeside Pkwy Ste 100, Flower Mound TX 75028-4026
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    USFDA