Events

Rappel de Siemens RAD Flouro Uro

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
    66314
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0140-2014
  • Date de mise en oeuvre de l'événement
    2013-09-03
  • Date de publication de l'événement
    2013-11-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-03-09
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122033
  • 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
    When using systems operating with software versions vd10a/g during a rad examination, a malfunction can result in radiation continuing longer than required resulting in an overexposed image that is not of diagnostic quality, prompting repetition of the examination.
  • Action
    Siemens sent an Field Safety Notice dated September 3, 2013, to all affected customers.The letter identified the product the problem and the action to be taken by the customer. Action to be taken: 1. It is not possible for the user to prevent this malfunction. The exposure time with the use of automatic exposure control is limited to 500ms, which is the maximum duration of radiation in this mode. The exposure can be interrupted by the user at anytime by releasing the exposure button. 2. There are two possibilities to solve this issue: a.) Switch off the system if the message "wait for FLC" in status bar does not disappear approximately. 30s after the OGP selection. The system gets ready after switching the system on and reselecting the Torno OGP. b.) Press Shift+F10. The pop up message has to be confirmed and you have to wait approximately. 40s until! the "i" icon in the status bar stops blinking. After that a RAD OGP has to be selected and then the Torno OGP. Thereafter, the system gets ready. 3. It is not possible for the user to prevent this malfunction The Center for Devices and Radiological Health (CDRH) understands that your Corrective Action Plan (CAP) will involve 59 units and consist of the following elements: 1. You have notified affected customers with Field Safety Notice XP032/13/S. 2. You have prepared a field modification of the Luminos dRF and Uroskop Omnia systems with software version VD10A/G. 3. Distribution of this field modification will began in September 2013 as Update Instruction XP015/13/S at no cost to the user. For further Customer Support call (610) 219-6300.

Device

Siemens RAD Flouro Uro
  • Modèle / numéro de série
    Model numbers 10094910 and 10094200 with software version VD10A/G.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Canada.
  • Description du dispositif
    Siemens RAD Fluoro Uro system (Luminos dRF and Uroskop Omnia with software version VD10A/G || Image intensified Fluoroscopic 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