Events

Retiro De Equipo (Recall) de Device Recall Infant Radiant Warmer

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
    77287
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2323-2017
  • Fecha de inicio del evento
    2017-05-05
  • Fecha de publicación del evento
    2017-05-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-07-12
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155625
  • 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
    Warmer, infant radiant - Product Code FMT
  • Causa
    Ge healthcare has recently become aware of a potential safety issue related to loose screws in the heater head of the infant warmer system (iws). hot screws from the heater head of the iws could fall onto the bed if the heater head assembly has been improperly serviced. this situation can be clinically hazardous because thermal injury to a patient could result. two injuries have been reported as a result of this issue.
  • Acción
    GE Healthcare sent an Urgent Medical Device Correction letter dated May 5, 2017, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Product Correction : Attached to this letter, we provide instructions as part of a Service Manual Addendum on how to correct the issue. Please add this new Addendum to the Service Manual of your device(s) and train the affected users accordingly. Please acknowledge that you have received this letter and that you understand that an action needs to be taken on your part to correct this issue by filling out and returning the attached Customer Response form. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative. Please be assured that maintaining a high level of safety and quality is our highest priority. If you have any questions, please contact us immediately per the contact information above.

Device

Device Recall Infant Radiant Warmer
  • Modelo / Serial
    Medical device listing number: D103053, D103054, D103056, D103057, D183529
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) Distribution.
  • Descripción del producto
    Infant Warmer System (IWS)
  • 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