Events

Rappel de Device Recall SOMATOM Definition Flash

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
    73593
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1520-2016
  • Date de mise en oeuvre de l'événement
    2016-03-02
  • Date de publication de l'événement
    2016-04-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-12-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144614
  • 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
    Software bugs in these somatom systems could possibly cause scan aborts, rescans of patients with additional dose, delayed diagnosis and as worst case scenarios, could possibly cause the need of additional contrast medium, accidental x-radiation to the user or impede customer workflow.
  • Action
    Siemens initiated a Customer Advisory Notice on 03/07/2016 to inform customers about actions for bug-fixing the following systems: SOMATOM Definition AS, SOMATOM Definition Flash and SOMATOM Definition Edge, which could possibly cause scan aborts, res cans of patients with additional dose, delayed diagnosis and as worst case scenarios, could possibly cause the need of additional contrast medium. Siemens mailed certified as well as via email distribution a Customer Advisory Notice to their customers to inform them about corrective actions for bug-fixing the following systems running with software version VA44A_SP3a, VA44A_SP3b, VA44A_SP3c, correction of potential safety issues. The issues described will be corrected with software VA44_SP4, handled as update CT051/15/P. Following the installation of this update, the mentioned malfunctions will be corrected.

Device

Device Recall SOMATOM Definition Flash
  • Modèle / numéro de série
    Model Number: 10430603 SOMATOM Definition family of CT systems running on software versions VA44A_SP3a, VA44A_SP3b, VA44A_SP3c.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution-including DC, and Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.
  • Description du dispositif
    Siemens SOMATOM Definition Flash; Intended to produce cross-sectional images of the body. Computed tomography (CT) x-ray system.
  • 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