Events

Retiro De Equipo (Recall) de Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1

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 GE Medical Systems China Co., Ltd..

¿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
    78469
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0579-2018
  • Fecha de inicio del evento
    2017-10-11
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=159630
  • 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
    Gas-machine, anesthesia - Product Code BSZ
  • Causa
    Possible incomplete seal between the co2 absorber and the breathing circuit co2 bypass port assembly of the carestation 600 series systems.
  • Acción
    On approximately 10/11/2017 customers were notified of the recall via letter. Instructions include that if elevated FiCO2 is observed, to increase the flow of fresh gas to reduce the volume of patient gas that is rebreathed. If the FiCO2 cannot be adequately reduced with this action, consider switching to another anesthesia delivery device. GE Healthcare is planning to release revised parts that minimize the likelihood of incomplete gas flow through the CO2 absorbent canister. GE Healthcare will correct all affected devices by installing updated parts at no cost to the customer. The updated parts will be included in the 12-month preventative maintenance schedule for the Carestation 600 Series System.

Device

Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1
  • Modelo / Serial
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed domestically to AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NV, NY, OH, OK, PA, TN, TX, UT, VA, VT, WA, WI, WV. Distributed internationally to Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Cote Di'Viore, Croatia, Czech Republic, Democratic Republic of Congo, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kenya, Korea (Republic of), Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Maldives, Malta, Mauritius, Mexico, Moldova, Morocco, Myanmar, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, Zimbabwe.
  • Descripción del producto
    Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1
  • Manufacturer
    GE Medical Systems China Co., Ltd.

Manufacturer

GE Medical Systems China Co., Ltd.
  • Dirección del fabricante
    GE Medical Systems China Co., Ltd., National Hi-Tech Dev. Zone, NO. 19 Changjiang Road, Wuxi China
  • Empresa matriz del fabricante (2017)
    General Electric Company
  • Source
    USFDA