Events

Retiro De Equipo (Recall) de Carestation 620 A2, Carestation 650 A2, and Carestation 650c A2

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-0580-2018
  • 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=159631
  • 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 A2, Carestation 650 A2, and Carestation 650c A2
  • Modelo / Serial
    Model No. 1012-9620-000, 1012-9650-000, 1012-9655-000, 1012-9650-002, 1012-9620-002, 1012-9655-002;   Serial No. SM617240023WA-A2, SM617240022WA-A2 SM617250011WA-A2 SM617240010WA-A2 SM617240011WA-A2 SM617240003WA-A2 SM617240012WA-A2 SM617240004WA-A2 SM717180002WA-A2 SM717250002WA-A2 SM717230002WA-A2 SM717250003WA-A2 SM717250011WA-A2 SM717250010WA-A2 SM817240005WA SM817240003WA SM817240004WA SM617230006WA SM617230066WA SM617230067WA SM617230068WA SM617230069WA SM617230070WA SM617230071WA SM617230072WA SM617230073WA SM617230074WA SM617230075WA SM617230076WA SM617230077WA SM617230079WA SM617230078WA SM617250041WA SM617250040WA SM617230081WA SM617230080WA SM617240009WA SM617240019WA SM617240016WA SM617240017WA SM617240018WA SM617240024WA SM617250012WA SM617250009WA SM617250005WA SM617250003WA SM617250019WA SM617250004WA SM617250010WA SM617250023WA SM617250022WA SM617250024WA SM617250028WA SM617250025WA SM617250026WA SM617250027WA SM617250029WA SM617250030WA SM617250031WA SM617250032WA SM617250033WA SM617250034WA SM617250038WA SM617250035WA SM617250039WA SM617250036WA SM617250037WA SM617320008WA SM617330010WA SM617330009WA SM617370027WA SM617230003WA SM617230002WA SM617250016WA SM617250013WA SM617250014WA SM617250015WA SM617250017WA SM617250020WA SM617250002WA SM617250001WA SM617360038WA SM617380014WA SM617250018WA SM617370028WA SM617240008WA SM617240005WA SM617240006WA SM617240007WA SM617280005WA SM617330008WA SM617330006WA SM617330007WA SM617370016WA SM617370087WA SM617370084WA SM617370085WA SM617370086WA SM617370088WA SM617370018WA SM617370017WA SM617370015WA SM617370008WA SM617250021WA SM617280015WA SM617280014WA SM617280016WA SM617280018WA SM617280022WA SM617280019WA SM617280020WA SM617280021WA SM617280023WA SM617280024WA SM617280025WA SM617280026WA SM617280027WA SM617280028WA SM617280029WA SM617280030WA SM617280031WA SM617280032WA SM617280033WA SM617290005WA SM617290006WA SM617290007WA SM617290008WA SM617280017WA SM617330023WA SM617370006WA SM617370004WA SM617370005WA SM617360037WA SM617380004WA SM617380001WA SM617380002WA SM617380003WA SM617380005WA SM617380006WA SM617380007WA SM617380008WA SM617380009WA SM617360004WA SM617370007WA SM617370022WA SM617370019WA SM617370020WA SM617370021WA SM617370023WA SM617370024WA SM617370003WA SM617370001WA SM617370002WA SM617370012WA SM617370009WA SM617370010WA SM617370011WA SM617370013WA SM617370014WA SM617360040WA SM617380013WA SM717250005WA SM717250007WA SM717320001WA SM717230003WA SM717230005WA SM717230004WA SM717260002WA SM717260001WA SM717370004WA SM717370003WA SM717250006WA SM717370001WA SM717250016WA SM717250014WA SM717250015WA SM717250013WA SM717330008WA SM717370002WA SM717370018WA SM817210001WA SM817210002WA SM717330016WA;   UDI No.: 010084068210398521SM617250012WA11170624, 010084068210398521SM617250003WA11170619, 010084068210398521SM617250004WA11170619, 010084068210398521SM617250010WA11170621, 010084068210398521SM617250013WA11170624, 010084068210394721SM717260002WA11170627, 010084068210394721SM717260001WA11170627, 010084068210395421SM817210001WA11170522, 010084068210395421SM817210002WA11170522
  • 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 A2, Carestation 650 A2, and Carestation 650c A2
  • 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