Events

Retiro De Equipo (Recall) de Precision Ice

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 Pro Trainers' Choice Company.

¿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
    58770
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2659-2011
  • Fecha de inicio del evento
    2011-04-18
  • Fecha de publicación del evento
    2011-06-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-03-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100276
  • 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
    Pack (hot/cold) water circulating - Product Code ILO
  • Causa
    The control panel of the precision ice one patient use control unit and wrap system has a overheating issue. the control panel printed circuit boards were missing a jumper connection across resistors r28 a, b, c, and d.
  • Acción
    Pro Trainers' Choice sent a Mandate-Medical Device Recall on April 18, 2011 and April 20, 2011 to all affected costumers. The letter included a description of the product, affected model and lots. It instructed the costumers to discontinue using the Precision Ice, Model 4BBK02BK until the device is returned and corrected by Pro Trainers' Choice. The device should be returned to PO Box 27, Kingston, WA 98346. The customers were instructed to notify their sub-account customers of this recall if the devices were further distributed. Customers can call Pro Trainers' Choice Company at 360-297-3902 or visit the website www.precisionice.com for any questions about this recall.

Device

Precision Ice
  • Modelo / Serial
    The affected serial numbers range from 100116 to 100452.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution including CA, CO, FL, IN, KS, NY, OR, TX, and WI.
  • Descripción del producto
    Precision Ice One-Patient-Use Control Unit and Wrap System (Model # 4BB02BK). || The device is intended to reduce edema and promote healing of soft-tissue injuries and lymphedema through stimulation of the lymphatic system. The device is a therapeutic system which consists of a control unit and fluid circulating pads. The pads are mounted in wraps designed for specific parts of the body such as ankle, knee, elbow, and shoulder. The pads provide cold treatment and pressure which help promote healing. || The owner's manual is labeled in part: "PRO TRAINERS' CHOICE COMPANY, INC.***www.precisionice.com***info@precisionice.com***Mailing Address PO Box 27***Kingston, WA 98346 USA***Phone: 360-297-3902***Shipping Address***26129 Calvary Lane NE, Suite 200***Kingston, WA 98346 USA***Fax: 360-297-3903". || The sticker which is placed on the back of the control board is labeled in part: "MOD#4BB02BK***SER#100***". || The shipping box is labeled in part: "Pro Trainers' Choice' LLC***Model #4BB02BK***Serial #100____***". || The knee wrap is labeled in part: "***Pro Trainers' Choice Co. Inc./Precision Ice One Patient Use Knee Wrap***#1BK01051KN***This device is to be used for one patient only; do not re-use!***".
  • Manufacturer
    Pro Trainers' Choice Company

Manufacturer

Pro Trainers' Choice Company
  • Dirección del fabricante
    Pro Trainers' Choice Company, PO BOX 27, 26129 Calvary Lane NE, Suite 200, Kingston WA 98346
  • Source
    USFDA