Retiro De Equipo (Recall) de Device Recall FL23SE MedSurg Bed

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 Medical Division 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
    65922
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2283-2013
  • Fecha de inicio del evento
    2013-08-19
  • Fecha de publicación del evento
    2013-09-26
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2014-01-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • 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
    Bed, ac-powered adjustable hospital - Product Code FNL
  • Causa
    The nurse call cable (part number: qdf23-0571) on the fl23se bed is located right under the opening of the bed head box. if an accessory (i.E. iv pole) is inserted into this slot, the circuit directing the nurse call system can be damaged.
  • Acción
    Stryker sent an Urgent Medical Device Recall Notification letter dated August 19, 2013, to all affected consignees. The notification described the affected product, reason for recall, potential hazards, and recall customer actions and reply instructions. A Stryker Representative will contact the consignees to arrange a time to repair the unit(s) and eliminate the risk of the potential interference . Urgent questions or concerns are directed to Blaine Burnett (269)389-6954. Stryker Medical business hours are Monday-Friday 8 a.m-5 p.m. (ET). For questions regarding this recall call 269-324-6609.

Device

  • Modelo / Serial
    Model Numbers: FL23SE with nurse call option: OL235017 & OL235018 List of Affected Devices: J60267 J60425 J60009 J60001 J60094 J60095 J60096 J60348 J60349 J60350 J60351 J60352 J60353 J60354 J60360 J60361 J60362 J60363 J60364 J60365 J60366 J60367 J60368 J60369 J60370 J60371 J60372 J60373 J60374 J60375 J60376 J60377 J60378 J60379 J60380 J60381 J60382 J60383 J60384 J60385 J60386 J60387 J60388 J60389 J60390 J60391 J60392 J60393 J60394 J60395 J60396 J60397 J60398 J60399 J60400 J60401 J60402 J60403 J60404 J60405 J60512
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including MI, WI, VA and internationally to Canada.
  • Descripción del producto
    The FL23SE Bed is an AC-powered adjustable hospital bed with four built-in electric DC motors and remote controls that is intended for medical purposes. It can be operated by the patient or the caregiver to adjust the height and surface contour of the bed. The bed includes movable and latchable siderails. The FL23SE Bed is intended for use with patients for procedures, therapy, recovery in healthcare environments, and to transport patients between bays and procedural rooms. || The FL23SE Bed is intended for use with patients for procedures, therapy, recovery in healthcare environments, and to transport patients between bays and procedural rooms.
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Stryker Medical Division of Stryker Corporation, 3800 E Centre Ave, Portage MI 49002-5826
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA