Events

Retiro De Equipo (Recall) de Corometrics Qwik Connect Plus Spiral Electrode

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
    63481
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0330-2013
  • Fecha de inicio del evento
    2012-10-16
  • Fecha de publicación del evento
    2012-11-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-04-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113969
  • 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
    Electrode, circular (spiral), scalp and applicator - Product Code HGP
  • Causa
    Thirty fetal scalp electrodes were found to have an incomplete package seal and lacked the printed lot number stamped on during sealing.
  • Acción
    The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter on October 16, 2012 via Fed Ex to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: DO NOT use Qwik Connect Plus Spiral Electrodes part number 7000AAO with lot number S03123 or product with missing lot numbers; isolate all affected product; complete and return the Urgent Medical Device Correction Confirmation form via fax at 800-535-7923, return form even if no recall product is in inventory; to return only unused product, and if they have forwarded any affected lot numbers of this product to any other healthcare institutions, forward a copy of this letter to those institutions. If you have any questions or concerns regarding this notification, 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

Corometrics Qwik Connect Plus Spiral Electrode
  • Modelo / Serial
    Lot #S03123 Model #7000AA0
  • Clasificación del producto
    Obstetrical and Gynecological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) including states: AZ, CA, CT, FL, GA, IL, KS, KY, MA, MD, MN, MO, NJ, NM, NY, OH, PA, SC,TX, WA, and WY; and countries of: Australia and Canada.
  • Descripción del producto
    Corometrics Qwik Connect Plus Spiral Electrode- Model #7000AA0 || A fetal scalp circular (spiral) electrode and applicator is a device used to obtain a fetal electrocardiogram during labor and delivery.
  • 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