Events

Rappel de Device Recall syngo Dynamics version 9.0

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
    58545
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2293-2011
  • Date de mise en oeuvre de l'événement
    2011-03-24
  • Date de publication de l'événement
    2011-05-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-07-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99559
  • 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
    If one or more graphs are in a table on the report, and if any of those graphs are deleted, it may lead to reports failing to save and/or marking the study as read might leave the study in an unread state or might mark the study as read but leave the report with a "preliminary" watermark displayed.
  • Action
    The firm, SIEMENS, sent a "Customer Safety Advisory Notice" letter dated March 24, 2011 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to place graphs in sections and not tables in the report; avoid deleting graphs from the reports in run-time and include this safety advisory notice in their operator's manual where it should remain until the service patch is applied. SIEMENS will be issuing a service patch to fix the defect. The letter states the patch will be available in the next few weeks. If you have any questions, call +1 (734) 205-2400.

Device

Device Recall syngo Dynamics version 9.0
  • Modèle / numéro de série
    10091602, 10091604
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution: USA including states of: CA, CT, FL, ID, MD, MI, MN, NJ, NY and PA.
  • Description du dispositif
    syngo Dynamics version 9.0, Siemens Medical Solutions, USA, Inc., Ann Arbor, MI. || The syngo Dynamics is a picture archiving and communications system intended for acceptance, transfer, display, storage, archiving and manipulation of digital medical images, including quantification and report generation. It is not intended to be used for the reading of mammography images.
  • Manufacturer
    Siemens Medical Solutions, USA, Inc

Manufacturer

Siemens Medical Solutions, USA, Inc
  • Adresse du fabricant
    Siemens Medical Solutions, USA, Inc, 400 Morgan Rd, Ann Arbor MI 48108
  • Source
    USFDA