Events

Retiro De Equipo (Recall) de Device Recall Thermal Angel

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 Estill Medical 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
    69242
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0101-2015
  • Fecha de inicio del evento
    2014-07-25
  • Fecha de publicación del evento
    2014-10-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-08-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130149
  • 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, blood, non-electromagnetic radiation - Product Code BSB
  • Causa
    Estill has discovered that a fully discharged ultra battery 1 (ta-ub1) will reach 96.9% of its capacity during a 60 minute charging period. if you have a fully discharged ultra battery 1 (ta-ub1), in order to achieve a 100% of charge capacity you should charge it for a period of 90 minutes. in addition, the charging voltage range of 10-36v specified on the ultra battery 1 (ta-ub1) label and in t.
  • Acción
    Thermal Angel sent a Notice of Corrections letter dated July 25, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to communicate the contents of the notice to all employees, consignees, consultants, or other parties affected by this correction. The firm also updated the labeling and instructions for use. For additional information cusotmers were instructed to contact Medical Technologies at (877)354-0286.The recalling firm issued a Notice of Corrections to its distributors and customers. For questions regarding this recall call 214-561-6001.

Device

Device Recall Thermal Angel
  • Modelo / Serial
    06-2011; 07-2011; 08-2011; 09-2011; 03-2012; 04-2012; 05-2012; 06-2012; 07-2012; 08-2012; 01-2013; 03-2013; 08-2013; 09-2013; 10-2013; 11-2013; 12-2013; 01-2014; 02-2014; 04-2014; 07-2012; 02-2014
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and Internationally to Serbia.
  • Descripción del producto
    Ultra Battery 1 Model: TA-UB1 NSN: 6515-01-592-5803 || The Ultra Battery 1 (TA-UB1) is a rechargeable power source for the Thermal Angel Blood and IV Fluid Infusion Warmer. The TA-UB1 battery was designed to provide sufficient power for the Thermal Angel to warm and deliver one liter of blood or IV fluid infusion to a trauma patient.
  • Manufacturer
    Estill Medical Technologies, Inc

Manufacturer

Estill Medical Technologies, Inc
  • Dirección del fabricante
    Estill Medical Technologies, Inc, 4144 N Central Expy Ste 260, Dallas TX 75204-3100
  • Empresa matriz del fabricante (2017)
    Estill Medical Technologies Inc.
  • Source
    USFDA