Events

Retiro De Equipo (Recall) de Device Recall General Purpose Temperature Probe

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 Vital Signs Devices, a GE Healthcare Company.

¿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
    65857
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1959-2013
  • Fecha de inicio del evento
    2013-07-18
  • Fecha de publicación del evento
    2013-08-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-01-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120513
  • 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
    Thermometer, electronic, clinical - Product Code FLL
  • Causa
    Ge healthcare has become aware of a potential safety issue associated with the use of ge general purpose 9 french temperature probe, disposable, 400 series [m1024229]. ges disposable general purpose 9fr temperature probe m1024229 is intended for oro-esophageal and rectal use. as it pertains to esophageal placement, it has been brought to our attention that some users are inserting the probe.
  • Acción
    The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated July 23, 2013 via Fed Ex beginning on July 29, 2013 to customers. The letter described the product, problem and actions to be taken. The customers were instructed to ensure that all potential users in your facility are made aware of this safety notification and the recommended actions. GE will update the Instructions for Use (IFU) and pouch label with new content related to insertion locations. GE has will also place the probe (M1024229) on quality hold until the new labeling changes are implemented. If you have any questions or concerns regarding this notification, please contact GEMSIT Customer Service at 1-800-588-7044 (Domestic) or Vital Signs Customer Service at 1-800-932-0760 (international). Hours of operation: 8:00 am EST to 6:00 pm EST.

Device

Device Recall General Purpose Temperature Probe
  • Modelo / Serial
    GE product number M1024229
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: US (nationwide) and countries of: Australia, Belgium, Canada, Czech Republic, Finland, France, Germany, Italy, Lebanon, Netherlands, Norway, Poland, Saudi Arabi, Singapore, South Africa, Spain, Sweden and United Kingdom.
  • Descripción del producto
    Disposable Temperature Probes, (sterile), Sensor diameter: 3mm/0.12 in; 25 units per box. Vital Signs Inc. a GE Healthcare Company, 20 Campus Road, Totowa, NJ 07512 USA, www.gehealthcare.com/vitalsigns. || Continuous temperature monitoring.
  • Manufacturer
    Vital Signs Devices, a GE Healthcare Company

Manufacturer

Vital Signs Devices, a GE Healthcare Company
  • Dirección del fabricante
    Vital Signs Devices, a GE Healthcare Company, 20 Campus Rd, Totowa NJ 07512-1210
  • Empresa matriz del fabricante (2017)
    General Electric Company
  • Source
    USFDA