Events

Retiro De Equipo (Recall) de OrthoCase 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
    75909
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0878-2017
  • Fecha de inicio del evento
    2015-10-08
  • Fecha de publicación del evento
    2016-12-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-06-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151678
  • 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
    Measurements in the software are changing after saving a plan with a measurement result, which may result in potential patient injury or delay in diagnosis or treatment.
  • Acción
    Merge issued a letter dated March 28, 2016, via email on April 4, 2016, or via certified mail if they did not have an email address for the customer. The letter notifies the customer of the issue, informs them of a workaround and that a fix is not yet available but they will be notified once one is available. 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. The response form asks, in part, if they are interested in accepting the fix. If they decline the fix, they are asked to provide the reason why. The response was required no later than April 18, 2016. Nonresponders were issued a second letter dated July 11, 2016, asking for a response by August 2, 2016. For further questions, please call (877) 741-5369.

Device

OrthoCase software
  • Modelo / Serial
    Versions: 2.0, 2.1, 2.1.1, 3.1, 3.2, 3.2.4, 3.3, 3.3.1, 3.4, 3.5.1, 3.5.1.1, 3.5.2, 3.5.3, 3.5.4, 3.5.5, 3.6, 3.6.1, 3.6.2, 3.7, 3.7.1, 3.7.2, 3.7.2 Vet, and 3.7.3
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distribution was made to medical facilities in CA, CO, CT, MA, MD, MN, MT, NE, NV, NY NJ, PA, SC, WA, and WI. Foreign distribution was made to Canada, as well as other countries.
  • Descripción del producto
    Merge OrthoCase software. The firm name on the label is Merge Healthcare, Hartland, WI.
  • Manufacturer
    Merge Healthcare, Inc.

Manufacturer

Merge Healthcare, Inc.