Events

Retiro De Equipo (Recall) de Device Recall EPIQ 5 Ultrasound System, Model: EPIQ 5G, EPIQ 5C, EPIQ 5W

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
    69790
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0816-2015
  • Fecha de inicio del evento
    2014-11-05
  • Fecha de publicación del evento
    2014-12-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-08-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131544
  • 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
    When using the qlab auto 2d quantification (a2dq) and auto cardiac motion quantification (acmq) applications, the reported end-systolic volume (esv) may be smaller, and the left ventricular ejection fraction (ef) may be higher, than the esv and ef calculated by manual tracing without the use of qlab. an incorrect ef calculation could lead to misdiagnosis and/or delayed or incorrect therapy.
  • Acción
    Philips has identified additional affected units and sent the Urgent-Field Safety Notice -Philips Ultrasound QLAB 10.0 (on Xcelera) letter, dated 2015/3/17, to their consignees. The FCO associated with this letter is FSN MA-FCO 83000190. The affected units identified as QLAB versions 10.0 with a2DQ and/or aCMQ plug-ins installed with Philips Xcelera software. QLAB software installed on Philips diagnostic ultrasound systems (carts) is the subject of a separate Field Safety Notice (FSN MA-FCO79500316 ). Philips has corrected this issue with QLAB version 10.2 on Xcelera and will contact customers to arrange installation of the upgrade to version 10.2 or higher free of charge. If consignees need any further information or support concerning the FCO 83000190, please contact your local Philips representative or Philips Customer Service at 1-800-722-9377. *************************************************************************************** Philips has begun sending out the URGENT - Medical Device Correction letters, dated 2014 NOV 05, for the Philips Ultrasound QLAB, Philips Model EPIQ 5 Ultrasound System, Philips Model EPIQ 7 Ultrasound System, and Philips Ultrasound Q-Station. The customer letter is also identified with the FSN # 79500316; 79500317; 79500318; or 79500321. The letters notified customers that Erroneous End-Systolic Volumes and Ejection Fraction May Be Reported When Using a2DQ & aCMQ (Auto 2D Quantification & Auto Cardiac Motion Quantification). Customers with questions should contact local Philips representative or Philips Customer Service at 1-866-767-7822.

Device

Device Recall EPIQ 5 Ultrasound System, Model: EPIQ 5G, EPIQ 5C, EPIQ 5W
  • Modelo / Serial
    SERIAL NUMBERS FOR FCO 79500317-EPIQ5 system:  US114B0005, US114B0006, US114C0193, US114C0209, US114C0239, US114C0240, US114C0241, US114C0271, US114C0272, US114C0273, US114C0284, US114C0286, US114C0287, US114C0308, US114C0331, US114C0334, US114C0366, US114C0751, US214C0043, US214C0106, US214C0140, US214C0143, US214C0144, US214C0416, US214C0417, US314C0199, US314C0298, US314C0447, US314C0728, US314C0745, US314C0800, US314C0801, US414C0012, US414C0066, US414C0114, US414C0157, US414C0158, US414C0159, US414C0395, US514C0081, USD13B0662, USD13C0033, USD13C0234, USD13C0290, USD13C0291, USD13C0481, USD13C0525, USD13C0526, USD13C0527, USD13C0572, USD13C0573, USD13C0584, USD13C0709, USN13B0039, USN13C0018, USN13C0182, USN13C0183, USN13C0184, USN13C0186, USN13C0206, USN13C0281, USN13C0282, USN13C0283, USN13C0284, USN13C0285, USN13C0286, USN13C0312, USN13C0361, USN13C0502, USN13C0503, USN13C0580, USN13C0654, USO13C0352, USO13C0354, USO13C0355, USO13C0356, USO13C0368, USO13C0369, USO13C0395, USO13C0396, USO13C0397, USO13C0398, USO13C0405, USO13C0453, USO13C0454, USO13C0596, USO13C0678, and USO13C0685.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution (for FCO 83000190): US, including the states of AK, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, NC, NJ, NY, OH, OR, PA, SC, SD, TN, TX, VA, WA, and WI; and the countries of United Arab Emirates, Austria, Australia, Belgium, Canada, Switzerland, Colombia, Germany, Ecuador, Estonia, Spain, Finland, France, Great Britain, Hong Kong, Israel, Italy, Japan, Luxembourg, Malaysia, Netherlands, Norway, New Zealand, Philippines, Saudi Arabia, Sweden, Singapore, Slovenia, Thailand, Turkey, Taiwan, and Vietnam. ********************************************************************************** Worldwide Distribution -- US, including the states of KY, TN, ME, CA, PA, NC, CT, NY, SC, IL, IN, and WI; and the countries of Argentina, Spain, India, Italy, Austria, Germany, Belgium, Canada, Finland, Switzerland, Greece, Malaysia, Sweden, Australia, Netherlands, Mexico, Peru, Taiwan, Japan, France, and Norway.
  • Descripción del producto
    EPIQ 5 Ultrasound System, EPIQ 5 systems with software versions 1.0.x or 1.1.x with QLAB a2DQ and/or aCMQ plug-ins are affected. Model: EPIQ 5G, EPIQ 5C, EPIQ 5W. Catalog Number: 795204 / 795205 and Part Number: 989605408541 || Diagnostic Ultrasound Imaging.
  • 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