Events

Rappel de Syngo Imaging XS

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
    53563
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0270-2010
  • Date de publication de l'événement
    2009-11-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-07-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85875
  • 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
    Picture archiving and communications system - Product Code LLZ
  • Cause
    Distorted image. the "distorted" image cannot be used for diagnostic findings, and, depending on the customer scenario, a repeated exam could be necessary if the image cannot be reported on any other workplace or recovered from another source.
  • Action
    The recalling firm issued a Customer Safety Advisory notice dated 9/14/09 to all affected customers via Update Instructions IM100/09/S. The notice informs the customer of the potential issue and provides instructions to avoid its occurrence. To avoid the potential risk of the issue, the local compression function can be disabled as described in the letter. Depending on the image data, the disabling of compression will result in increased storage usage. The issue will be resolved in the release of version VA70B. For all potentially affected customers with "JPEG Compression" license an update instruction will be released which defines the necessary corrective actions in case of "Distorted" images. The update instruction will be performed on request by the customer service group. Further questions regarding this issue are directed to the local SIEMENS Uptime Service Center or +49 (9131) 84-2056.

Device

Syngo Imaging XS
  • Modèle / numéro de série
    Model number 7502029 - Serial numbers: 9620, 9621, 9622, 9623, 9624, 9625, 9630, 9631, 9632, 9633, 9634, 9639, 9640, 12068, 12271, 13090, 13358, 13428, 13480, 13637, 13727, 13742, 13945, 13971, 13979, 14059, 14086, and 14960.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    The product was shipped to medical facilities in CA, FL, GA, IL, MD, MI, MO, NE, NC, NY, OH, PA, TN, TX, and WV.
  • Description du dispositif
    Syngo Imaging XS VA60 and VA70 in combination with JPEG Compression.
  • 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