Events

Retiro De Equipo (Recall) de Device Recall 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
    59767
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0338-2012
  • Fecha de inicio del evento
    2011-08-23
  • Fecha de publicación del evento
    2011-12-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-09-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103614
  • 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
    The caster with lock on the incubator may become loose or break.
  • Acción
    The firm, Atom Medical, sent an "Urgent: Field Safety Notice" letter dated August 18, 2011, to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately identify all devices in their inventory and quarantine them until the rework is complete; identify any customers to whom they have further distributed the product; contact their customers at once and arrange a time in which the field service technician can perform the rework (the parts needed to complete the rework will be sent from Atom Medical's export department ); complete rework of all affected devices and document rework on the Distributor FSCA/Recall Response Form and return via Fax to: +81 3 3812-3199 or email to kira-utc@atomed.co.jp; t-sugino@atomed.co.jp or kenichi.shimada@atomed.co.jp (all forms should be completed and returned by January 31, 2012.) If you have any questions, contact the Manager Quality Control or Manager, Regulatory Affairs at email addresses above, phone: +81-3-3815-3632 or fax +81-3-3812-3199.

Device

Device Recall Incu i
  • Modelo / Serial
    All lots on the market.  model 101
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) including state of: PA and countries of: Algeria, Austria, Australia, China, Egypt, Germany, Italy, Japan, Korea, Kuwait, Malaysia, Portugal, Russia, Saudi Arabia, Spain, Switzerland, Thailand, The Netherlands, and UAE.
  • Descripción del producto
    Incu i (Atom Infant Incubator Model 101) || 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