Events

Rappel de Device Recall ARTIS zee and zeego

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
    65651
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1782-2013
  • Date de mise en oeuvre de l'événement
    2013-06-26
  • Date de publication de l'événement
    2013-07-22
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-02-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119815
  • 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, angiographic - Product Code IZI
  • Cause
    Siemens issued a customer safety advisory notice and field safety corrective action for a potential issue on artis systems with artis vc20x/vc21a that have patch 7 and a 3d and dsa license installed. the issue affects-dsa rotational acquisition. the restriction is related to any rotational 3d-acquisition program with real-time subtraction (e.G. 3d dsa). during the fill phase of the rotational aqui.
  • Action
    Siemens sent a Customer Safety Advisory Notice dated June 26, 2013, to all affected customers. The letter identified the product, the problem, and the action needed to be taken by the customer. Customers were strongly recommend to carefully evaluate one of the following options before running 3D rotational acquisition programs that include real-time subtraction until a patch is installed on their system: 1) position the monitor in a way such that contrast advancement can be monitored during the fill phase on the live monitor in the control room. 2) For applications not requiring actions based on the contrast flow during the fill phase, the contrast may not need to be monitored during the fill phase. Although the monitor is not showing the expected subtraction, the acquisition is working correctly. There is no need to interrupt, but continue and finish the workflow. 3) Perform 3D rotational programs that include real time subtraction from the exam room. The display on the live monitor in the exam room is not affected by this problem. To resolve the issue, the update AX028/13/P (VC20x/VC21B), will be made available around July 2013, and scheduling an appointment for implementation of the update with Siemens Customer Service organization was recommended. If this device/equipment is no longer in theirr possession, customers were asked to forward this safety notice to the new owner and inform Siemens of the new user's identity.

Device

Device Recall ARTIS zee and zeego
  • Modèle / numéro de série
    Model numbers: 10094137, 10094139, 10094141, 10280959
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution and Puerto Rico
  • Description du dispositif
    ARTIS zee and zeego x-ray, angiographic system with Software Artis VC20x/VC21A that have Patch 7 and a 3D and DSA license installed. || Angiographic x-ray system
  • 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