Events

Retiro De Equipo (Recall) de Device Recall Victory 10, 3 Wheel (SC610)

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 Pride Mobility Products 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
    59438
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-3211-2011
  • Fecha de inicio del evento
    2011-06-22
  • Fecha de publicación del evento
    2011-09-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-11-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102794
  • 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
    Vehicle, motorized 3-wheeled - Product Code INI
  • Causa
    Contract manufacturer error. component part(s) (fuses) specifications were not adhered to as outlined in pride's engineering drawings.
  • Acción
    Pride Mobility Products Corp. sent a "RECALL OF VICTORY 3 AND 4 WHEEL UNITS; REPLACEMENT OF FUSES" letter dated June 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. Customers are asked in the letter to locate their affected Victory unit(s) and inform users of the recall. A letter has been provided by the firm to distribute to users alerting them to the recall. Additionally, customers are to set up an appointment with users to replace the fuses. Customers are instructed to contact Pride's Upgrade department at 866-222-6212 to order the kit and for questions regarding this recall. .

Device

Device Recall Victory 10, 3 Wheel (SC610)
  • Modelo / Serial
    Victory 10, 3 Wheel
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) including the District of Columbia and Puerto Rico and the states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY and countries of Australia, Canada, France, and United Kingdom.
  • Descripción del producto
    Victory 10, 3 Wheel (SC610) || Mobility medical device
  • Manufacturer
    Pride Mobility Products Corp

Manufacturer

Pride Mobility Products Corp
  • Dirección del fabricante
    Pride Mobility Products Corp, 182 Susquehanna Ave, Exeter PA 18643
  • Empresa matriz del fabricante (2017)
    Pride Mobility Products Corp
  • Source
    USFDA