Events

Retiro De Equipo (Recall) de Device Recall MicroMaxx ultrasound system and MTurbo 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 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
    59442
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0057-2012
  • Fecha de inicio del evento
    2011-07-18
  • Fecha de publicación del evento
    2011-10-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-09-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102808
  • 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
    This is a software anomaly. in some circumstances, if the systolic/diastolic (s/d) ratio value is interpreted directly from the display, the clinician could potentially use an incorrect value of the s/d ratio in his/her assessment.
  • Acción
    The firm SonoSite, Inc., sent an "Urgent - Medical Device Correction" letter dated September 29, 2011 to its foreign and domestic customers. The letter described the product, problem, and actions to be taken. The customers were instructed to follow the three (3) steps provided in the letter to verify if the extended OB/GYN Calculations (EOBC) is enabled on their system. Additionally, SonoSite will perform a software upgrade to M-Turbo and/or MicroMax ultrasound system in order resolve the issue. The customers were instructed to contact Sonosite Technical Support via website: www.sonosite.com/sdratio; email: regulatory@sonosite.com (include contact information and address), or call in U.S. and Canada: 1-877-590-4982. If you have any questions or concerns regarding this matter, do not hesitate to contact in US and Canada at 1-877-657-8118, Monday-Friday, 6 am-5 pm PST. Customer can also send an email to Technical Support at service@sonosite.com

Device

Device Recall MicroMaxx ultrasound system and MTurbo ultrasound system
  • Modelo / Serial
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) including Puerto Rico; and countries of: Afghanistan, Algeria, American Samoa, Argentina, Australia, Bolivia, Botswana, Brazil, Canada, China, Costa Rica, Cyprus, Dominican Republic, Estonia, France, Gambia, Germany, Great Britain, Guam, Guatemala, Honduras, Hong Kong, Hungary, India, Iran, Ireland, Italy, Japan, Jordan, Kenya, Korea, Kuwait, Mauritius, Mexico, Netherlands, New Zealand, Nigeria, Northern Mariana Islands, Oman, Panama, Paraguay, Peru, Philippines, Portugal, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, Tanzania, Uganda, United Arab Emirates, Viet Nam, and Zambia.
  • Descripción del producto
    MicroMaxx ultrasound system and M-Turbo ultrasound system is Medical Diagnostic Ultrasound. || General purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body.
  • Manufacturer
    Sonosite, Inc.

Manufacturer

Sonosite, Inc.
  • Dirección del fabricante
    Sonosite, Inc., 21919 30th Dr SE, Bothell WA 98021-3904
  • Empresa matriz del fabricante (2017)
    FUJIFILM Holdings Corp.
  • Source
    USFDA