Events

Rappel de Device Recall Siemens Artis Q/Q.zen

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
    76016
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0972-2017
  • Date de mise en oeuvre de l'événement
    2016-12-08
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151943
  • 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
    Interventional fluoroscopic x-ray system - Product Code OWB
  • Cause
    Siemens initiated a corrective action to address two possible, mutually independent causes of a system defect related to the following: - in artis systems with a100 plus or a100g generators, an attempt to resume operation following detection of a fault can result in the failure of a module in the high-voltage generator. - for biplane systems delivered with software version vd11b since april of this year, software problems in conjunction with graphics card may, in rare cases, result in the loss of image display in the examination room.
  • Action
    Siemens mailed a Customer Safety Advisory Notice (CSAN) dated December 8, 2016, to all affected customers with Customer Safety Advisory Notice AX002/16/S. Additionally, Siemens has initiated a software update via Update Instruction AX001/16/S. Their Service Organization will contact each customer to schedule an appointment to perform the corrective action; however, customers can make contact for an earlier appointment. Customers with questions should call 1-888-826-9702. For questions regarding this recall call 610-448-6461.

Device

Device Recall Siemens Artis Q/Q.zen
  • Modèle / numéro de série
    Model # 10848280, 10848281, 10848282, 10848353, 10848354, 10848355
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    Artis Q/Q.zen, Angiographic x-ray system || Stand alone system || The Artis systems are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis zee/ zeego and Q/ Q.zen include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee/ zeego and Q/ Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis
  • 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