Events

Rappel de Device Recall Siemens Luminos dRF, Ysio or Uroskop Omnia 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
    68785
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2292-2014
  • Date de mise en oeuvre de l'événement
    2014-07-07
  • Date de publication de l'événement
    2014-09-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-02-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128661
  • 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, fluoroscopic, image-intensified - Product Code JAA
  • Cause
    It was discovered that during a rad examination using siemens luminos drf, ysio or uroskop omnia systems with software version vb10c to vb10f and automatic exposure control, a highly unlikely malfunction can result in longer radiation exposure than required. this may also result in an overexposed image that is not of diagnostic quality. as a result the taken examination needs to be repeated. thi.
  • Action
    Siemens had informed all affected customers about this issue via Customer Safety Advisory Notice XP023/13/S (dated June 3, 2013) reported under C&R; # 2240869-05/16/13-0013-C. A corresponding software update to fix the issue was originally planned to be rolled out by May 2014. The originally scheduled roll out date could not be met and to ensure that this new software version works accurately Siemens incorporated a comprehensive monitoring phase. Siemens has now scheduled the roll out for the software version VB10J to be completed by end of October 2014. A letter, dated July 7, 2014, with important safety information was sent to end users to notify them that the new software version VB10J will be introduced to solve the potential malfunction of the generator.

Device

Device Recall Siemens Luminos dRF, Ysio or Uroskop Omnia systems
  • Modèle / numéro de série
    model numbers 10094200, 10281163, 10281013, 10094910 with multiple serial numbers
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution.
  • Description du dispositif
    Siemens Luminos dRF, Ysio or Uroskop Omnia systems. || The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies.
  • 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
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    USFDA