Events

Retiro De Equipo (Recall) de 3.7 V LiPolymer Battery

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 Invivo Corporation.

¿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
    50790
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0971-2009
  • Fecha de inicio del evento
    2008-08-13
  • Fecha de publicación del evento
    2009-02-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-11-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=77307
  • 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
    Batteries used with Cardiac Monitor - Product Code MWI
  • Causa
    Battery failure: the invivo lithium polymer wireless module battery part number 9065 and the lithium polymer fiber optic module battery part number 9067 is being recalled because the battery, itself, when dropped from 3 feet/1 meter onto a hard surface can produce a flame and then emit smoke. the firms investigation shows that the battery failure does not occur when a module is dropped with a ba.
  • Acción
    Urgent Medical Device Recall Notice letters, dated August 2008, and response forms were mailed to each consignee. Distributors were instructed to forward copies of the recall letter and response forms to their customers. The letters identified the affected products, gave the reason for the recall, the hazard involved, how to identify the product, actions to prevent the failure, and procedures to mitigate risk if failure occurs. The letter stated that Invivo would provide replacement batteries but until replacements were provided, customers should handle batteries over an elevated area and to make sure batteries are handled in the absence of paper or other flammable materials. If customers wish to remove the battery from the module in order to conserve battery life, they are to disengage the battery from the module and place the battery on a table or in the battery charger. Do not allow the battery to be disengaged and remain partially inserted in the module as this may cause the battery to slip from the module and fall to the floor.

Device

3.7 V LiPolymer Battery
  • Modelo / Serial
    date codes 2808 and lower.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution
  • Descripción del producto
    3.7 V Li-Polymer Battery, used in Precess MRI Compatible Patient Monitoring System and Achieva, Intera and Panorama 1.0T. REF 9065 or REF 9067. Invivo Corporation, Orlando, FL 32826 || These rechargeable batteries are used to supply power to patient monitoring system's wireless modules and gating/triggering systems' fiber optic modules.
  • Manufacturer
    Invivo Corporation

Manufacturer

Invivo Corporation
  • Dirección del fabricante
    Invivo Corporation, 12501 Research Pkwy, Orlando FL 32826-3280
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    USFDA