Events

Retiro De Equipo (Recall) de Device Recall Voluson Pro/Expert

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 General Electric Med. Sys. Ultrasound.

¿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
    35066
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1172-06
  • Fecha de inicio del evento
    2006-02-24
  • Fecha de publicación del evento
    2006-06-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-01-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45212
  • 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
    In the cardiac measurement section of the device the calculation of the 'pg mean' (mean pressure gradient) leads to an erroneous result. it is recommended that customers with affected units do not use the measurement in question 'pg mean' for any diagnostic or therapeutic decision, and 'pg mean' values should not be included in any patient documentation.
  • Acción
    An Urgent Medical Device Correction letter to customers 04/17/2006, states the product affected, provides a recommendation for affected units continued use until a software update is provided to the facility by a GE Healthcare Representative. Customers are recommended to not use the measurement in question 'PG Mean' for any diagnostic or therapeutic decision, and 'PG mean' values should not be included in any patient documentation.

Device

Device Recall Voluson Pro/Expert
  • Modelo / Serial
    Software versions 4.0.0, 4.0.1, 4.0.2, 4.0.3, 4.0.4, 4.0.5, 5.00, 5.0.1. Serial number ranges A06251 thru A09914, A12012 thru A31198 and A35001 thru 35097 may include devices that are not subject to the correction.  Serial number ranges A10000 thru A11087 and A31201 thru A33742 only include devices subject to the correction
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide, Puerto Rico and OUS to include: Algeria, Argentina, Austria, Belgium, Bosnia and Herzegovina, Brazil, Republic of Bulgaria, Byelorussian SSR, Canada, China, Croatia, Cyprus, Czech Republic, Denmark, DVU Australia, Ecuador, Egypt, Finland, France, Federal Republic of Germany, Greece, Hong Kong, Republic of Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Korea, Kuwait, Republic of Lithuania, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Paraguay, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Kingdom of Saudi Arabia, Singapore, Republic of Slovenia, Spain, Sudan, Sweden, Switzerland, Taiwan, United Republic of Tanzania, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, Venezuela, Vietnam, Yemen, Yugoslavia
  • Descripción del producto
    Voluson 730 Expert, Voluson 730 Pro, Voluson 730 ProV with software versions 4.0.0, 4.0.1, 4.0.2, 4.0.3, 4.0.4, 4.0.5, 5.00, 5.0.1. The device is a general-purpose diagnostic ultrasound system.
  • Manufacturer
    General Electric Med. Sys. Ultrasound

Manufacturer

General Electric Med. Sys. Ultrasound
  • Dirección del fabricante
    General Electric Med. Sys. Ultrasound, 4855 W Electric Ave, West Milwaukee WI 53219-1628
  • Source
    USFDA