Events

Rappel de Siemens AXIOM Luminos dRF Max system

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
    69258
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0003-2015
  • Date de mise en oeuvre de l'événement
    2014-09-02
  • Date de publication de l'événement
    2014-10-02
  • 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=130370
  • 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 KPR
  • Cause
    Two malfunctions posing potential risk to patients were identified with siemens ysio max, axiom luminos drf max, uroskop omnia max, and luminos agile max systems with a specific set of serial numbers that will cause lost images due to an automatic radiology information system (ris) worklist update, thus causing examinations to be repeated. image label may also be displayed incorrectly after images.
  • Action
    Siemens sent a Safety Advisory Notice, dated September 2, 2014, to all affected customers. The Notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to disable the automatic RIS worklist update and perform this procedure manually. Customers should disable the Measurement Field Display and Collimator Display by setting the display time for both setting to 0 sec (if editable). Customers should forward the safety notice to the new owner and inform Siemens of the new owner where possible. Customers with questions should call 610-219-2119 or 610-219-4834. For questions regarding this recall call 610-219-6300.

Device

Siemens AXIOM Luminos dRF Max system
  • Modèle / numéro de série
    Siemens AXIOM Luminos dRF Max system material #s: 10762471 with serial number: 5037.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution - US including UT, MO, CO, MA, MN, MS, OH, SC, MI, and NY.
  • Description du dispositif
    Siemens AXIOM Luminos dRF Max systems || The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. The Axiom Luminos dRF is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image.
  • 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