Retiro De Equipo (Recall) de Device Recall Spirit Select 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 CHG Hospital Beds Inc.

¿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
    74560
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2332-2016
  • Fecha de inicio del evento
    2016-06-28
  • Fecha de publicación del evento
    2016-08-03
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2017-06-08
  • 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
    Stryker medical is initiating a voluntary recall of the spirit select and spirit plus a-c powered hospital beds due to reports of hi-lo actuators broken at the mount ends, which could cause the bed to unexpectedly lower resulting in patient injury.
  • Acción
    The firm, Stryker Medical, issued an "URGENT MEDICAL DEVICE RECALL" letter dated 7/8/2016 by FedEx to its customers and included a revised preventive maintenance checklist. The letter described the product, problem and actions to be taken. The customers were instructed to: locate the units listed on the attached business reply form; remove these units from service, if not possible to remove units from service, place units in the height position according to instructions; file the revised preventative maintenance checklist; return the Business Reply Form to confirm receipt of the notification by fax (269)488-8691 or email productfieldaction@stryker.com. If customers have loaned or sold any of the beds listed in this letter, please forward a copy of the recall notice to the new users and advise us of their new location in the space provided on the business reply form. Your Stryker Field service Representative will contact your facility to add support brackets to your beds. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. " Online: www.fda.gov/medwatch/report.htm " Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to MedWatch , P.O. Box 3002, Rockville, MD 20847-3002 " Fax: 1-800-FDA-0178 If you have any questions or concerns, please contact Stryker Customer Service (1-800-327-0770). Our normal business hours are Monday-Friday 8 a.m-6 p.m. (EST).

Device

  • Modelo / Serial
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: US (nationwide) including states of: AK , AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, and WI; and country of: Canada
  • Descripción del producto
    Spirit Select Bed, A-C Powered Hospital Bed
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    CHG Hospital Beds Inc, 153 Towerline Place, London Canada
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA