Events

Retiro De Equipo (Recall) de Device Recall EPIQ DIAGNOSTIC ULTRASOUND 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 Philips Ultrasound, 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
    73665
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1380-2016
  • Fecha de inicio del evento
    2016-03-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-12-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144689
  • 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
    System, imaging, pulsed doppler, ultrasonic - Product Code IYN
  • Causa
    The fasteners securing the control panel assembly to the base of the philips epiq ultrasound system may loosen over time, which could subsequently lead to the detachment of the entire assembly from the ultrasound system.
  • Acción
    The firm, Philips, sent an "Urgent-Medical Device Correction" Philips EPIQ Ultrasound System (MDC 79500381/2), letter dated 2016 MAR 23 to consignees on 3/28/16. The letter describes the product, problem and actions to be taken. The customers were instructed to review the information with all members of your staff who need to be aware of the contents of this communication. If, at any time, the control panel assembly on your ultrasound system wobbles or feels loose, stop using your system immediately and contact your local Philips representative or Philips Customer Service at 1-800-722-9377. Otherwise, you may continue to use your system. Philips will contact all EPIQ customers to arrange for service to replace the fasteners connecting the control panel assembly to the system with fasteners less likely to loosen with repeated handling. This service will be performed free of charge. If you need any further information or support concerning this issue, please contact your local Philips representative or Philips Customer Service at 1-800-722-9377.

Device

Device Recall EPIQ DIAGNOSTIC ULTRASOUND SYSTEM
  • Modelo / Serial
    All Serial numbers
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: US (nationwide) including Washington, D.C., and countries of: Algeria, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Belgium, Bermuda, Bolivia, Brazil, Brunei Darussalam, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Malta, Martinique, Mayotte, Mexico, Monaco, Mongolia, Morocco, Myanmar, Netherlands, New Caledonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, State of, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, R¿¿union, Romania, Russia , Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, and Viet Nam.
  • Descripción del producto
    EPIQ DIAGNOSTIC ULTRASOUND SYSTEM, Model EPIQ 5C, EPIC 5G, EPIQ 5W, EPIQ 7C, EPIC 7GC, and EPIQ 7W. || Diagnostic Ultrasound System for ultrasound imaging in abdominal, cardiac adult, cardiac other (fetal), cardiac pediatric, cerebral vascular, cephalic (adult), cephalic (neonatal), fetal/obstetric, gynecological, intraoperative (vascular), intraoperative (cardiac), musculoskeletal (conventional), musculoskeletal (superficial), other: urology, pediatric, peripheral vessel, small organ (breast, thyroid, testicle), transesophageal (cardiac), trans rectal, transvaginal.
  • Manufacturer
    Philips Ultrasound, Inc.

Manufacturer

Philips Ultrasound, Inc.
  • Dirección del fabricante
    Philips Ultrasound, Inc., 22100 Bothell Everett Hwy, Bothell WA 98021-8431
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    USFDA