Events

Rappel de Device Recall Siemens syngo.plaza

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
    65719
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1975-2013
  • Date de mise en oeuvre de l'événement
    2013-03-04
  • Date de publication de l'événement
    2013-08-15
  • 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=119958
  • 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, image processing, radiological - Product Code LLZ
  • Cause
    Siemens issued a customer safety notice to inform customers of a potential problem when using syngo.Plaza. in some instances, it can happen that the laterality information in mammography images is not displayed and these images may not be properly aligned to mammography segments.
  • Action
    The firm, Siemens, notified their customers on March 4, 2013 and sent a "Customer Safety Advisory Notice" letter dated April 03, 2013. The letter described the product, problem and actions to be taken. The customers were instructed to always check whether the laterality information is displayed in the image text of mammography images; if not, the DICOM header is accessible and can be checked for the tag "Laterality" (0020, 0060). If a system is not able to provide the DICOM tag "Image Laterality" (0020, 0062), configuring the image text by adding the tag was proposed. If you have sold the device/equipment and it is no longer in your possession, forward this safety notice to the new owner of the device/equipment and inform us about the new owner of the device/equipment. This issue will be resolved in the syngo.plaza software version VA20D_HF04 which is planned to be released in 02/2013. Customers were also instructed to contact the local Siemens service office to plan the update. If you have any questions, contact the SYNGO CEO or Vice President Quality at +49 (9131) 84-4874 or email to: michael.mlb.braun@siemens.com.

Device

Device Recall Siemens syngo.plaza
  • Modèle / numéro de série
    Model number 10592457, serial numbers 100219, 100201, 100473. Update dated 5/13/13 included the following additional serial numbers: 100177, 100504, 100174, 100181, 100473, and 100539.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution: FL, MA, KS, NY, OH, PA, TX and WI.
  • Description du dispositif
    Siemens syngo.plaza SW version VA20 with Mammography license. || image processing, radiological 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