Events

Retiro De Equipo (Recall) de AirStrip Sense4Baby Model C Fetal Monitor

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 AirStrip Technologies, Inc..

¿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
    74963
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2829-2016
  • Fecha de inicio del evento
    2016-08-04
  • Fecha de publicación del evento
    2016-09-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-11-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148904
  • 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
    Home uterine activity monitor - Product Code LQK
  • Causa
    Belt clip may become detached causing electronic components to be exposed.
  • Acción
    The firm sent out customer notification letters on August 4, 2016. Customers were instructed to cease distribution and use of the device and notify any customers in possession of it. Customers were informed that Airstrip would make arrangements to return the affected Central Units to AirStrip for correction at AirStrips expense. If customers have not been contacted by AirStrip to make these arrangements call AirStrip tollfree at 1 (877) 258-5869. For further questions, please call (210) 805-0444.

Device

AirStrip Sense4Baby Model C Fetal Monitor
  • Modelo / Serial
    Serial Number: C2386DA70E C2386EC9CD C2386ECAF3 C2386EC9CE C2386EC9B6  C2386EC9C5  C2386EC9C0  C2386EC9CB  C2386DA70D  C2386EC9AF  C2386EC9B7  C2386EC9CF  C2386EC9B4  C2386DA718  C2386ECAF5  C2386EC9B5  C2387684D9  C2386DA771  C2386EC9B8  C2386EC9D4  C2386EC9C3  C2386EC9B3  C2386ECAFA  C2386EC4C4  C2386EC9C9  C2386EC9D3  C2386ECAE6  C2386DA77E  C2386EC9B1  C2386DA715  C2386EC9CE  C2386EC9BC  C2386ECB36  C2386EC9C1  C2386EC9DC  C2386ECAF8  C2386DA786  C2386ECAFB  C2386EC9AE  C2386EC9C8  C2386EC9D0  C2386ECAEE
  • Clasificación del producto
    Obstetrical and Gynecological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    U.S. distribution to the following; AR, LA. Foreign distribution to the following; South Africa, Netherlands.
  • Descripción del producto
    AirStrip Sense4Baby Model C Fetal Monitor || The Sense4Baby System Model C is indicated for monitoring of maternal and fetal physiologic parameters during the antepartum period. The Sense4Baby System is to be used by health care professionals or patients, by prescription or doctor s order, in hospitals, clinics, physicians offices, antepartum rooms, or outside a hospital or health care setting. The data interpretation is to be done by a health care professional.
  • Manufacturer
    AirStrip Technologies, Inc.

Manufacturer

AirStrip Technologies, Inc.
  • Dirección del fabricante
    AirStrip Technologies, Inc., 565 Pearl St Ste 209, La Jolla CA 92037-5050
  • Empresa matriz del fabricante (2017)
    AirStrip Technologies Inc.
  • Source
    USFDA