Events

Retiro De Equipo (Recall) de Device Recall syngo Dynamics

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 Siemens Medical Solutions USA, 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
    65603
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1859-2013
  • Fecha de inicio del evento
    2013-06-10
  • Fecha de publicación del evento
    2013-08-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-02-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119697
  • 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
    Siemens initiate this recall due to a potential issue when using the sdis matching rules of the syngo dynamics information system version 9.5 or va10a with modality device configured to end study at association close. images or dicom sr objects sent from a modality device to syngo dynamics may not be saved when the modality is configured at syngo dynamics to end study at association close, and whe.
  • Acción
    Siemens sent a Customer Safety Advisory Notice dated June 4, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. 1) With sDIS implemented, use the DICOM Modality List (DMWL), without sDIS matching rules enabled OR 2) Do not implement sDIS. Update instructions were also provided. The reported issue will be resolved in a modification to syngo Dynamics version 9.5 and syngo Dynamics VA10A which will be released in the near future. We regret any inconvenience that this may cause , and we thank you in advance for your understanding. For further questions please call (610) 219-6300.

Device

Device Recall syngo Dynamics
  • Modelo / Serial
    Model Number: 10091637, 10091805, with serial numbers 85164, 85289, 85296, 85297, 85149, 85116, 85177, 85051, and 85278.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution only including the states of PA, OH, UT, CA, NY, MO, and TX.
  • Descripción del producto
    syngo Dynamics Information System (sDIS) versions 9.5 and VA10A. || The syngo¿ Dynamics system is intended for the acceptance, transfer, display, storage, archive, and manipulation of digital medical images, including quantification and reportgeneration. || syngo¿ Dynamics is not intended to be used for reading mammography images.
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Dirección del fabricante
    Siemens Medical Solutions USA, Inc, 51 Valley Stream Pkwy, Malvern PA 19355
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    USFDA