Events

Retiro De Equipo (Recall) de Device Recall Merge PACS 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 Merge Healthcare, Inc..

¿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
    75629
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0599-2017
  • Fecha de inicio del evento
    2016-03-28
  • 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=150960
  • 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
    System, image processing, radiological - Product Code LLZ
  • Causa
    The software did not show unviewed images when the last view was skipped. the physician may potentially misdiagnose when not all images are available for viewing.
  • Acción
    The recalling firm issued a letter dated March 28, 2016 via e-mail or via certified mail to customers. The letter identified the affected product, problem and actions to be taken. The notification instructs the customer to pass the information onto all other users, as well as any downstream customers if it was further distributed. The notification also informs the customer their response is required using the enclosed form and the return addressed envelope.

Device

Device Recall Merge PACS software.
  • Modelo / Serial
    Versions: V6.0 MR2, 6.0 MR3, 6.0 MR3 CU, 6.0 MR4, 6.0 MR4 CU1, 6.0 MR4 CU2, 6.0 MR4 CU3, 6.0 MR4 CU4, 6.0 MR4 CU5, 6.0 MR4 CU6, 6.0 MR4, CU7, 6.0 MR4 CU8, 6.0 MR4 CU9, 6.0 MR4 CU10, 6.0 MR4 CU11, 6.1, 6.1.1, 6.1.2, 6.1.3, 6.2, 6.2.1, 6.2.2, 6.2.3, 6.2.4, 6.2.5, 6.3, 6.4, 6.4.1, 6.4.2, 6.4.3, 6.4.4, 6.4.5, 6.4.6, 6.4.7, 6.5, 6.5.5, 6.5.6, 6.5.7, 6.5.8, 6.5.9, 6.6, 6.6.1, 6.6.1.1, 6.6.2, 6.6.2.1, 6.6.2.2, 7.0, 7.0.1, and 7.0.2.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide including Canada.
  • Descripción del producto
    Merge PACS software. || Product Usage: || Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication and storage of studies produced by digital modalities, including digital mammography.
  • Manufacturer
    Merge Healthcare, Inc.

Manufacturer

Merge Healthcare, Inc.