Events

Retiro De Equipo (Recall) de Device Recall Widefield OCT software

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 Heidelberg Engineering.

¿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
    79453
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1535-2018
  • Fecha de inicio del evento
    2017-12-08
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162348
  • 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
    Tomography, optical coherence - Product Code OBO
  • Causa
    Fda notified heidelberg engineering that a 510(k) clearance is needed for the spectralis widefield oct feature, and, on november 27, 2017, heidelberg engineering submitted a new 510(k) for this feature. fda has asked heidelberg engineering to instruct customers not to use the widefield oct software feature on the spectralis device until 510(k) clearance has been obtained for this software feature.
  • Acción
    On December 14, 2017 an URGENT Medical device software field correction letter was issued to customers via email or ground mail to notify all customers of the recall action. The letter states the following: FDA has asked us to instruct you not to use the Widefield OCT feature on your SPECTRALIS device until a decision is made on this pending 510(k) submission. Heidelberg Engineering will notify you immediately upon completion of the FDAs review. In the meantime, you may continue to use your Widefield Objective for cSLO fundus imaging (including Fluorescein Angiography, ICG Angiography, MultiColor, Infrared and Red-Free Fundus Imaging). Questions or concerns can be directed to (508) 530-5904

Device

Device Recall Widefield OCT software
  • Modelo / Serial
    The Widefield OCT software feature was made available on the SPECTRALIS Software US versions 6.3 to 6.8a It is only usable with the Widefield Objective Module accessory and a dedicated license.
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationally
  • Descripción del producto
    Widefield OCT software feature for the Spectralis HRA+OCT and variants
  • Manufacturer
    Heidelberg Engineering

Manufacturer

Heidelberg Engineering
  • Dirección del fabricante
    Heidelberg Engineering, 10 Forge Pkwy, Franklin MA 02038-3137
  • Empresa matriz del fabricante (2017)
    Heidelberg Engineering Inc.
  • Source
    USFDA