Events

Rappel de Device Recall Syngo.plaza Picture Archiving and communications systems

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
    76639
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1533-2017
  • Date de mise en oeuvre de l'événement
    2017-02-20
  • Date de publication de l'événement
    2017-03-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-08-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153715
  • 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
    Software updates.
  • Action
    Siemens mailed a notification letter dated February 21, 2017 to affected customers to inform them of the software updates that were now available to address several issues. Customers were advised to follow the instructions in the notice and where necessary promptly notify and instruct all their staff at their organization who have to be aware of the problem. Customers were also instructed to forward the information to new owners where possible. For questions regarding this recall call 610-219-4834.

Device

Device Recall Syngo.plaza Picture Archiving and communications systems
  • Modèle / numéro de série
    Device Model Number: 10863171, 10863173 Serial Numbers: 100213 100484 100362 100457 100314 100300 100306 100307 100449 100450 100247 100221 100212
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution to MO,TX, FL, MA, WI, PA, IN, and CA
  • Description du dispositif
    Syngo.plaza, Picture Archiving and Communications System (PACS) || Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo.plaza also supports storage and archiving of DICOM Structured reports. In a comprehensive imaging syngo.plaza integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer specific workflows. Syngo.plaza optionally uses a variety of advanced postprocessing applications
  • 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