Events

Retiro De Equipo (Recall) de Device Recall PowerPark

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 Sonosite, 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
    55874
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2116-2010
  • Fecha de inicio del evento
    2010-05-27
  • Fecha de publicación del evento
    2010-08-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-04-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92115
  • 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
    Ultrasonic Pulsed Doppler Imaging System - Product Code IYN
  • Causa
    Powerpark system has a potential for loss of power at the corresponding wall outlet and/or circuit due to poor alignment.
  • Acción
    On 05/27/10, SonoSite began contacting their consignees by telephone. On 06/01/10, SonoSite sent out the URGENT-MEDICAL DEVICE RECALL letter to their consignees. The letter describes the recall product as SonoSite PowerPark. Customers should call the Technical Support at 1-877-657-8118 or e-mail to service@sonosite.com for any questions regarding the recall. The letter instructs consignees to stop using the PowerPark immediately and return the product back to SonoSite in exchange for a full refund. The consignees will be contacted by the firm's Sales Representative and/or Clinical Applications Specialist to schedule an appointment to retrieve the device and deliver a refund.

Device

Device Recall PowerPark
  • Modelo / Serial
    Serial numbers for the Stand Mounted Assembly (P12822):  03J5RJ; 03J5G2; 03J5RX; 03J5GC; 03J5FN; 03J5RH; 03J5BL; 03J5FF; 03J5D1; 03J5CV; 03J5D0; 03J5GN; 03J4RB; 03J5D4; 03J5G9; 03HPVK; 03J5T3; 03HPVF; 03J4RD; 03J5D3; 03J5G1; 03J5FD; 03J5G5; 03J5CZ; 03J4RC; and 03J4RG.      Serial numbers for the Docking Assembly (P12834):  03J4R0; 03J4R1; 03J5CY; 03J4R4; 03J520; 03J5FK; 03J5G7; 03J5G8; 03J51R; 03J5BF; 03J5BH; 03J4R6; 03J5GJ; 03J5GG; 03J5FL; 3J4RX; 03J5GK; 03J0GR; 03J5RR; 03J5G6; 03J5RC; 03J5FJ; 03J5G5; 03J5RV; 03J5GH; and 03J5RF.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA, including states of GA, NM, PA, TX, VA, and WA and country of Australia.
  • Descripción del producto
    PowerPark is an accessory to the V or H Universal Stand and comprised of two parts: the stand mounted assembly (P12822) and a docking assembly (P12834). The stand mounted assembly is mounted to the V or H Universal stand and the docking assembly is plugged into a wall circuit. It provides a docking and charging station for the V and H Universal Stands. || The product marketing brochure labeled in part: "SonoSite Ltd...21919 30th Drive SE... Bothell, WA 98021, USA".
  • Manufacturer
    Sonosite, Inc.

Manufacturer

Sonosite, Inc.
  • Dirección del fabricante
    Sonosite, Inc., 21919 30th Dr Se, Bothell WA 98021-3904
  • Source
    USFDA