Retiro De Equipo (Recall) de Device Recall Digital Pathology System (DPS) Software, version 1.1

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 Omnyx Llc.

¿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
    66596
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0469-2014
  • Fecha de inicio del evento
    2013-10-01
  • Fecha de publicación del evento
    2013-12-09
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2014-04-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • 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
    Research Use Only devices - Product Code OTU
  • Causa
    There is an issue associated with digital pathology system (dps) software, in which the annotation tools within the dps version 1.1 image viewer will display incorrect measurements and area calculations for a region of interest on a scanned slide, under certain conditions.
  • Acción
    Omnyx sent a Urgent Field Safety Notice letter dated October 1, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Please discontinue use of the measurement and area calculation features of the annotation tools (line, rectangle/square, ellipse/circle, and freeform) in the DPS Image Viewer at this time. If any of these tools have been used for measurements or area calculations on clinical cases, verify measurements and calculations on glass slides. Please confirm receipt of these instructions by completing the attached form and scanning/emailing it to FieldAction@ omnyx.com or faxing it to 001-412-894-2137 Product Correction: An updated version of the DPS SW will be released and installed on your system as soon as it becomes available. Please note that the appropriate regulatory authorities have been informed of this field action. We apologize for any inconvenience that this may have caused you and are working diligently to address this issue. If you have any additional questions or concerns, please contact you GE Healthcare account representative. Further questions please call (412) 891-2100.

Device

  • Modelo / Serial
    catalog # OMN-1005056-1, K1600LH, DPS 1.1
  • Clasificación del producto
  • Clase de dispositivo
    Not Classified
  • ¿Implante?
    No
  • Distribución
    International Distribution to Canada and Switzerland only.
  • Descripción del producto
    Digital Pathology System (DPS) Software version 1.1 || The Omnyx" Integrated Digital Pathology system, which consists of a whole slide scanner and associated software applications, is a scanning, receiving, storing, managing, annotating and computer monitor viewing system for digital whole slide images. Omnyx" products are for in vitro diagnostic use for specific clinical applications, and are intended for research use only on other applications. Specific clinical use applications are indicated in separate clinical specific user guides supplied by Omnyx.
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Omnyx Llc, 30 Isabella St, Pittsburgh PA 15212-5862
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA