Events

Rappel de Device Recall SOMATOM Definition AS

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
    73639
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1350-2016
  • Date de mise en oeuvre de l'événement
    2016-03-22
  • Date de publication de l'événement
    2016-04-08
  • 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=144645
  • 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 became aware that the front cover on some siemens ct system was not properly welded. it is possible for the welded-in threaded bolt to break out of the ground plate of the front cover if the cover is opened during service. this could not happen during clinical operation. therefore, there is no potential risk for the user or patient and the ct system has no risk for a malfunction during clinical operation.
  • Action
    Siemens sent an "Informational Only" notice to customers on 03/22/2016 informing them to be aware that the front cover on some Siemens CT systems was not properly welded. The letter was only to notify customers that the issue is being addressed with the completion of a service visit. In addition, Siemen plans to replace each cover and hand delivered each notification to customers at the time the service is performed.

Device

Device Recall SOMATOM Definition AS
  • Modèle / numéro de série
    Model Number: SOMATOM Definition AS-8098027 Serial # SOMATOM Definition AS- 95766
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed to: Cincinnati, OH.
  • Description du dispositif
    SOMATOM Definition AS, a family of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission dta from either the same axial plane taken at different angles or spiral planes taken at different angles.
  • 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