Events

Retiro De Equipo (Recall) de Device Recall Dual Incu i

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 Atom Medical 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
    61807
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1945-2012
  • Fecha de inicio del evento
    2012-05-01
  • Fecha de publicación del evento
    2012-07-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-01-31
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109139
  • 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
    Incubator, neonatal - Product Code FMZ
  • Causa
    There is a potential for the device's canopy to move unintentionally when using the incubator mode or radiant warmer mode.
  • Acción
    Atom Medical sent an Urgent Field Safety Notice dated May 1, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately identify all affected product in their inventory and quarantine them until the rework was complete. Customers were also asked to identify any customers to whom they further distributed the product and to contact their customers at once and arrange a time in whcih the filed service technician could perform the rework. Customers were asked to return the Recall Response Forms to Atom Medical (kirautc@atomed.co.jp, tsugino@atomed.co.jp, or matsumoto@atomami.co.jp). All forms should be completed and returned by January 31, 2013. For questions regarding this recall call 512-327-9997.

Device

Device Recall Dual Incu i
  • Modelo / Serial
    All lots on the market of model 100
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including PA. Internationally to Japan, Kuwait, Saudi Arabia, Lenanon, Italy, Spain, China, East Europe, Slovakia, Poland, Czech Republic, Ukraine, Egypt, Russia, Algeria, Colombia, Germany, Malaysia, Switzerland, Australia, Europe, Portugal, Iran, Israel, Philippines, UAE, Korea, and Netherlands
  • Descripción del producto
    Dual Incu i, (Atom Infant Incubator Model 100) Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033 Usage: An incubator for infants.
  • Manufacturer
    Atom Medical Corporation

Manufacturer

Atom Medical Corporation
  • Dirección del fabricante
    Atom Medical Corporation, 3-18-15 Hongo, Bunkyo-Ku Japan
  • Empresa matriz del fabricante (2017)
    Atom Medical Corporation
  • Source
    USFDA