Events

Rappel de Device Recall Syngo.via, syngo.x

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
    71314
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1705-2015
  • Date de mise en oeuvre de l'événement
    2015-05-15
  • Date de publication de l'événement
    2015-06-03
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-03-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137299
  • 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
    Measurements drawn on the 2nd and subsequent images of the series are not visible on printouts when the series is sent to print.
  • Action
    Siemens sent a Customer Advisory Notice, dated May 15, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to check the software version of their syngo.via system and consider whether the issue described in the advisory notice impact their clincal coutine and whether to arrange the installation of SY027/15/P (VA30A_HF07). Customers were advised to include the advisory notice in their operator's manual. Customers were also advised to notify anyone at their organization who should be aware of this information. For questions regarding this recall call 610-219-6300.

Device

Device Recall Syngo.via, syngo.x
  • Modèle / numéro de série
    Model Number of device: 10496180, with serial numbers:  220755 101060 100509 220783 100662 220844 130208 102213 100862 101739 102125 102401 102402 130118 102024 102509 102477 102008 100751 101802 102089 101559 102407 130252 220915 220909 130267 101118 101313 101114 130180 100735 100495 102295 102532 220684 220725 102265 101638 102377 101432 102158 101864 130161 102374 102025 220511 102340 102197 101938 101647 100929 220206 100729 101201 101051 101220 101202 101206 101854 220448 220466 101565 100530 101612 102381 101561 220879 130174 102100 102418 100220 102120 220593 101137 101740 220577 102336 130125 101701 102335 101419 100748 101885 101578 101341 100460 102108 102175 100692 130122 101371 130378 100675 100700 101257 130229 220617 102021 100760 101338 102281 100718 101309 220888 101631 220920 100796 102405 220512 102435 100075 101444 100957 100039 102417 101043 101042 101066 220521 102127 101546 100705 220855 102420 102146 220742 102486 101797 101754 100633 102363 220743 130266 220454 100603 102074 101953 102173 102063 100892 100753 102163 220876 130140 130269 100734 101316 100845 101958 101200 101852 100484 220900 101038 101057 102355 100978 102014 130173 100917 101266 100389 101010 101650 100742 102360
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    Syngo.via and Syngo.x ; a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Adresse du fabricant
    Siemens Medical Solutions USA, Inc, 51 Valley Stream Pkwy, Malvern PA 19355-1406
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    USFDA