Events

Rappel de Siemens SOMATOM Force

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
    75594
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0692-2017
  • Date de mise en oeuvre de l'événement
    2016-10-20
  • Date de publication de l'événement
    2016-12-02
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-05-30
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150867
  • 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, x-ray, tomography, computed - Product Code JAK
  • Cause
    Siemens is providing software update version va50a_sp3 to address the software bugs that were identified through normal field monitoring and the global complaint handling process. correction for the problems are as follows: 1. correction to volumetric misrepresentations of high contrast objects when using admire. 2. correction to highly sporadic scan aborts due to temporarily tube currents at 0ma. 3. correction to missing microsoft hotfixes (ms16-001, ms15-135, ms15-088, ms15-048). 4. correction to highly sporadic image artifacts caused by error signals from high voltage chain at extremely high tube currents. 5. correction to highly sporadic incomplete image reconstruction due to temporary slow hard disk write speed. 6. correction to highly sporadic scan aborts due to temporarily high disk load of system disk. 7. correction to highly sporadic image artifacts generated by scatter correction in case of tube arcings.
  • Action
    Siemens sent a Customer Information Letter dated November 2, 2016, to customers affected by the recall to inform them of a release of a software update that will provide bug-fixes to improve system performance. Customers will be contacted to arrange a date for onsite installation. For further questions, please call (610) 448-6471.

Device

Siemens SOMATOM Force
  • Modèle / numéro de série
    Model Number 10742326, Serial Numbers: 75708,75709,75607,75617,75550,75526 75512,75567,75536,75711,75514,75600,75563,75510,75454,75540,75571,75500 75527,75475,75535,75481,75482,75710,75460,75476,75588,75493,75458,75528 75467,75602,75487,75464,75478,75604,75513,75532,75555,75524,75515,75559 75610,75501,75570,75616,75576,75605
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution.
  • Description du dispositif
    SOMATOM Force, System x-ray, tomography, computed
  • 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