Events

Rappel de Device Recall Syngo.via software

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Siemens Medical Solutions USA, Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    79513
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1261-2018
  • Date de mise en oeuvre de l'événement
    2018-01-10
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162538
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    System, image processing, radiological - Product Code LLZ
  • Cause
    When the archiving configuration is changed, data received/created after the upgrade may be flagged as "not to be archived". this is caused by the automatic function for cleaning up temporary data being disabled by the software upgrade. due to the disabled cleanup function, disc capacity for free space decreases faster than usual. unless the archiving configuration and the cleanup automatic function are reverted back to the original state (prior to the software upgrade), data that was incorrectly flagged "not to be archived" must be manually prevented from being deleted by either clinical administrator or service engineer.
  • Action
    Customers received letters with information related to the issue and regarding the upgrade to the software version VB20A_HF04. The software was released December 22, 2017 and is available for install.

Device

Device Recall Syngo.via software
  • Modèle / numéro de série
    All Syngo.via systems with VB20A. Model number 10496180.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Medical device software which needs to be installed.
  • Description du dispositif
    Syngo.via software is intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a standalone device or together with a variety of cleared and unmodified syngo based software options.
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Adresse du fabricant
    Siemens Medical Solutions USA, Inc, 40 Liberty Blvd, Malvern PA 19355-1418
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    USFDA