Rappel de Device Recall Siemens Medical Solutions USA

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
    68932
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2713-2014
  • Date de mise en oeuvre de l'événement
    2014-07-28
  • Date de publication de l'événement
    2014-09-29
  • Statut de l'événement
    Terminated
  • Pays de l'événement
  • Date de fin de l'événement
    2016-12-23
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
  • 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, tomography, computed, emission - Product Code KPS
  • Cause
    Siemens medical solutions usa, inc. is performing a field correction because we recently detected a rubber isolator with unfavorable aging properties. the function of the rubber isolator, which is situated within the rotate motor mounting assembly, may degrade over time and may impact motor support. the event does not pose a hazard by itself but could lead to a rupture of the drive belt which in t.
  • Action
    Siemens sent an Undated Customer Safety Advisory Notice letter to all direct accounts (customers). The letters included instructions for customers to: 1) continue to use the system(s) while waiting for the field correction to be scheduled and performed unless the system exhibits abnormal noise or vibration in which case the system(s) should not be used and the local Siemens Medical Solutions USA service engineer should be contacted; 2) ensure that the letter is placed in the Systems Owner's Manual and share it with support staff; and, 3) if the product was sold to another party, forward the letter to that party. A local service engineer will contact the customer to schedule the servicing of the affected systems by December 2014 which will consist of replacing the mounting plate. If customers have any questions about this issue, customer can contact their local service representative by calling 800-888-7436.

Device

  • Modèle / numéro de série
    1) Symbia Intevo Excel; Product Code: 10764801; Serial Numbers: 1001 , 1002 , 1003 , 1004 , 1005 , 1006 , 1007 , 1008,  1009 , 1010 , 1011 , 1012 , 1013 , 1014 ;   2) Symbia Intevo 2; Product Code: 10764802; Serial Numbers: 1001 , 1002 , 1003 , 1004 , 1005 ,  2001;   3) Symbia Intevo 6; Product Code: 10764803; Serial Numbers: 1001 , 1002 , 1003 , 1004 , 1005 , 1006 , 1007 , 1008 , 1009 , 1010 , 1011 ,  1012,  2001;   4) Symbia Intevo 16; Product Code: 10764804; Serial Numbers: 1001 , 1002 , 1003 , 1004 , 1005 , 1006 , 1007 , 1008 , 1009 , 1010 , 1011 , 1012 , 1013 , 1014 , 1015
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including AL, AK, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WAM WI, WY, District of Columbia, Puerto Rico and Internationally to Algeria, Argentina , Australia , Austria , Bangladesh , Belgium , Brazil , Bulgaria , Canada , Chile , China, Colombia , Croatia , Czech Republic , Denmark , Ecuador , Egypt , Finland , France , Germany , Hong Kong , Hungary , India , Indonesia , Iran , Ireland , Israel , Italy , Japan , Kazakhstan , Korea, Kuwait , Latvia , Libya , Lithuania , Malaysia , Mexico , Morocco , Myanmar , Netherlands , New Zealand , Norway , Oman , Pakistan , Peru , Philippines , Poland , Portugal , Qatar , Romania , Russia, Saudi Arabia , Singapore , Slovakia , Slovenia , South Africa , Spain , Sweden , Switzerland , Taiwan , Thailand , Tunisia , Turkey , United Arab Emirates , Ukraine , United Kingdom , Vietnam
  • Description du dispositif
    The Symbia Intevo series consists of the Intevo 16, Intevo 6 and Intevo 2. This manual also describes the Symbia Intevo Excel. The Symbia Intevo series integrates state-of-the-art SPECT and high quality spiral CT to provide precise attenuation correction and anatomical mapping. The system can also be used as a complete clinical SPECT system for general purpose, whole body (WB) and SPECT applications. || The Symbia Intevo Excel integrates state-of-the-art SPECT and high quality spiral CT to give the system SPECT functionality, with attenuation correction. || The Symbia Intevo 2 integrates state-of-the-art SPECT and high quality dual slice spiral CT to give the system full functionality for all SPECT-only, xSPECT, or stand-alone CT diagnostic applications in Oncology, Neurology, and Cardiology. || The Symbia Intevo 6 integrates state-of-the-art SPECT and high quality six slice spiral CT to give the system full functionality for all SPECT-only, xSPECT, or stand-alone CT diagnostic applications in Oncology, Neurology, and Cardiology. || The Symbia Intevo 16 integrates state-of-the-art SPECT and high quality sixteen slice spiral CT to give the system full functionality for all SPECT-only, xSPECT, or stand-alone CT diagnostic applications in Oncology, Neurology, and Cardiology. || Indications for use: SPECT: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV. CT: The CT component is intended to produce cross sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial place taken at different angles or spiral planes taken at different angles. SPECT+CT: Perform CT scans and nuclear imaging studies within the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patient's anatomy.
  • Manufacturer

Manufacturer

  • Adresse du fabricant
    Siemens Medical Solutions USA, Inc., 2501 Barrington Rd, Hoffman Estates IL 60195-2061
  • Société-mère du fabricant (2017)
  • Source
    USFDA