Events

Retiro De Equipo (Recall) de Device Recall Optima MR430s MRI Scanner

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 Healthcare, LLC.

¿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
    64885
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1212-2013
  • Fecha de inicio del evento
    2013-03-28
  • Fecha de publicación del evento
    2013-05-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-10-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117262
  • 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, nuclear magnetic resonance imaging - Product Code LNH
  • Causa
    Coolant supply lines may leak liquid onto the floor resulting in a slippery surface and fall hazard.
  • Acción
    GE Healthcare sent an Urgent Medical Device Correction letter dated April 23, 2013, to all affected customers. The letter informed customers of a potential safety issue due to leakage from gradient coolant lines. Consignees were instructed to monitor the floor for leakage and continue to use if leakage is not observed. If leakage is observed consignees are instructed to stop using the system and notify their local service representative. GE Healthcare will correct all affected scanners by providing an update at no cost. Customers with questions were instructed to contact their local service representataive. For questions regarding this recall call 262-513-4122.

Device

Device Recall Optima MR430s MRI Scanner
  • Modelo / Serial
    08022011-001; 09092011-001;12102011-001;05152012-004;SM11062012-001;02022012-001;08142012-001;04212012-001;05252012-002;12132011-001;SM08292012-007;11052011-002;01192012-001;01132012-001;06282012-010;07252012-001;01022012-001;11202011-001;08142011-001;06302011-001;09172011-001;10082011-001;10172011-002;03142012-007;06142012-001;06212012-001;07172012-001;07232012-001;SM09132012-003;02042012-001;01132012-001;07172011-001;09062011-001;09242011-001;SM10122012-003;M12102012-003;05102012-004;08022012-003;07302012-008;SM01072013-005;05032012-004;08032012-001;10172011-001;SM08152012-001;12262011-001;10092011-001;04172012-001;11052011-001;07112011-001;10242011-007;07222011-001;08102011-001;03092012-001;05172011-001;06222011-001;03202012-004;05182012-001;07112012-002;06092011-001;01232012-001;02162012-001;11262012-007;SM12172012-001;01212012-001;SM10232012-001;11212011-001;12222011-001;SM11132012-002;06012011-001;07132011-001;12042011-001;03062012-007;03282012-001;10272011-009;12142011-001;10302012-006;02112012-001;03062012-008;01272012-001;05162012-003;03262012-002;11292011-001;06112012-004;10172012-001;12102012-001
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including AL, CA, CO, FL, ID, IL, MA, NH, NJ, NY, OH, PA, SC, SD, TN, TX, UT, VA, WA, WI; Worldwide: Argentina, Australia, Austria, Brazil, Canada, Chile, Denmark, Egypt, Finland, Germany, India, Italy, Japan, Korea, Malaysia, Netherlands, Norway, Peru, Poland, Russia, Singapore, South Africa, Spain, Sweeden, Switzerland, UK, Ukraine, and UAE.
  • Descripción del producto
    Optima MR430s MRI Scanner; 5000-0002 || is indicated to use as a magnetic resonance imaging device of the leg (excluding the thigh), knee, ankle, foot, elbow, forearm, wrist, and hand.
  • Manufacturer
    GE Healthcare, LLC

Manufacturer

GE Healthcare, LLC
  • Dirección del fabricante
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Empresa matriz del fabricante (2017)
    General Electric Company
  • Source
    USFDA