Events

Retiro De Equipo (Recall) de Device Recall Intracranial pressure 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 Spiegelberg Gmbh & Co. KG.

¿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
    75160
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2888-2016
  • Fecha de inicio del evento
    2009-12-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-10-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149491
  • 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
    Device, monitoring, intracranial pressure - Product Code GWM
  • Causa
    In the vast majority of products specified, a shrinkage of the air chamber during sterilization has occurred. because of these false high readings were displayed in the lower measuring range from 0 to 20 mmhg. the observed measurement error was particularly at the lowest end of the range (to 0 mmhg) up to 8 mmhg.
  • Acción
    Spiegelberg Gmbh & Co. KG sent an Urgent Medical Device Recall letter dated December 29, 2009, to all affected customers. Customers were instructed to quarantine and return stored products. Furthermore, they were asked to inform all their customers which have received the affected products and recall the products accordingly. Furthermore, they were asked to tell us about the actions taken by them.

Device

Device Recall Intracranial pressure monitor
  • Modelo / Serial
    Probe 3PN SND1 3.1 .53/FV534P: SNs: 12835-1 3393;  Probe 3PS SND13.1 .63/FV535P: SNs: 6937-7122
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution to PA only
  • Descripción del producto
    Spiegelberg Brain Pressure Monitoring System || Probe 3PN, REF: SNDI3.1.531FV534P and Probe 3PS, REF: SNDI3.1.63/FV535P || Product Usage: lntracranial pressure measuring probes are used to measure intracranial pressure (intracranial pressure, ICP), so the pressure in the head.
  • Manufacturer
    Spiegelberg Gmbh & Co. KG

Manufacturer

Spiegelberg Gmbh & Co. KG
  • Dirección del fabricante
    Spiegelberg Gmbh & Co. KG, Tempowerkring 4, Hamburg Germany
  • Empresa matriz del fabricante (2017)
    Spiegelberg GmbH & Co. KG
  • Source
    USFDA