Events

Rappel de Device Recall ICON 9.5 Software

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
    25541
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-0727-03
  • Date de mise en oeuvre de l'événement
    2003-02-10
  • Date de publication de l'événement
    2003-04-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2005-01-19
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26005
  • 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, Tomographic, Nuclear - Product Code JWM
  • Cause
    Icon 9.5 software does not apply flood corrections during whole body spect studies with multiple bed positions.
  • Action
    Siemens sent Customer Advisory letters dated 2/10/03 to all ICON 9.5 customers with Whole Body SPECT functionality on integrated camera systems including Diacam, Multispect 2, Multispect 3 and e.cam camera systems aquired on an ICON workstation. The accounts were informed of the problem related to applying the flood correction matrix to Whole Body SPECT studies in ICON version 9.5 software, and were provided the follwoing workaround: To ensure that the flood correction is applied, the user should acquire multiple single bed positions with the General SPECT predefine, indexing the bed manually between each SPECT acquisition. The data can then be combined into a Whole Body SPECT in the Whole Body SPECT Display program for review. In addition, users were requested to routinely perform standard quality control procedures at the facility to ensure proper image quality. No software upgrade is planned.

Device

Device Recall ICON 9.5 Software
  • Modèle / numéro de série
    All Diacam, Multispect 2, Multispect 3 and e.cam camera systems with ICON workstations with ICON software version 9.5 and the optional Whole Body SPECT software.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide, United Arab Emirates, Argentina, Austria, Australia, Barbados, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Equador, Egypt, France, Germany, Great Britain, Georgia, Greece, Hong Kong, Israel, India, Italy, Jordan, Japan, Korea, Latvia, Mexico, Niger, Norway, New Zealand, Philippines, Pakistan, Poland, Russia, Saudi Arabia, SIngapore, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine and the Netherlands.
  • Description du dispositif
    ICON 9.5 Software used on the ICON workstations designed for use with the E.CAM Emission Imaging Computed Tomography Systems; Siemens Medical Systems, Inc., Nuclear Medicine Group, Hoffman Estates, IL 60195-5203
  • Manufacturer
    Siemens Medical Solutions USA, Inc.

Manufacturer

Siemens Medical Solutions USA, Inc.
  • Adresse du fabricant
    Siemens Medical Solutions USA, Inc., 2501 N. Barrington Road, Hoffman Estates IL 60195-5203
  • Source
    USFDA