Events

Retiro De Equipo (Recall) de Device Recall Game Ready Professional Therapy System

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 CoolSystems, 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
    59826
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-3210-2011
  • Fecha de inicio del evento
    2011-08-23
  • Fecha de publicación del evento
    2011-09-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-11-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103818
  • 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
    Massager, powered inflatable tube - Product Code IRP
  • Causa
    It was discovered that some game ready professional therapy system units that were to have been quarantined pending final inspection and testing were inadvertently moved to finished goods inventory and shipped.
  • Acción
    The firm, CoolSystems, Inc., contacted customers by phone on August 23, 2011. The customers were informed that some Game Ready Professional Therapy System units have been quarantined pending final inspection and testing were inadvertently moved to finished goods inventory and shipped. Instructions were given to immediately cease fulfilling orders from that inventory. Loaners were shipped to the customers overnight. The customers were instructed to replace the shipped device with the loaner that was sent and return it to the company ASAP. If you have any questions, contact the Vice President, Quality Assurance and Regulatory/Clinical Affairs at 510-868-5378.

Device

Device Recall Game Ready Professional Therapy System
  • Modelo / Serial
    Model number 550100. Serial numbers: 290617, 217039, 210225, 217061,211091, 217116, 211172, 217422, 211933, 30218115, 212258, 30218182, 214099, 30218591, 214204, 30218660, 215233, 30218661, 215693, 30218712, 216203, 30220291, 216641, 30221427, 216858, 30221743.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution: CA, MA, MO, NH, OH, TX, UT, and WA.
  • Descripción del producto
    Game Ready Professional Therapy System, || a cryotherapy device. || Intended to treat postsurgical and acute injuries to reduce edema, swelling and pain where indicated.
  • Manufacturer
    CoolSystems, Inc.

Manufacturer

CoolSystems, Inc.
  • Dirección del fabricante
    CoolSystems, Inc., 1201 Marina Village Pkwy, Suite 200, Alameda CA 94501-1087
  • Empresa matriz del fabricante (2017)
    Coolsystems, Inc.
  • Source
    USFDA