Events

Rappel de Device Recall e.cam

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
    25546
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0623-03
  • Date de mise en oeuvre de l'événement
    2003-02-10
  • Date de publication de l'événement
    2003-03-06
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2004-09-15
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26012
  • 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
    Unexpected release of the radial and rotate brakes in the case of multiple simultaneous fault conditions.
  • Action
    Siemens sent Customer Advisory letters dated 2/10/03 to all e.cam customers. The accounts were informed of the problem with unexpected camera movement when multiple fault cocnditions are presnet, causing the brake system to release and the roation of the detector assemblies, and were advised to use the emergency stop at any indication of improper camera movement. The customers were advised that they would be contacted by their Siemens Customer Service Representative to schedule a firmware upgrade that will prevent the occurrence of unintended release of the radial and rotate brakes. The upgrade will be done free of charge.

Device

Device Recall e.cam
  • Modèle / numéro de série
    All e.cam towers, serial numbers 00013 through 08543, utilizing e.soft, ICON-S and duet acquisition systems, and e.soft and ICON-S COIN systems.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide, United Arab Emirates, Argentina, Austria, Australia, Bosnia, Barbados, Bangladesh, Belgium, Bolivia, Brazil, Camaroon, Canada, Chile, China, Colombia, Republic of Congo, Czech Republic, Denmark, Dominican Republic, El Salvador, Equador, Egypt, France, Finland, Germany, Great Britain, Georgia, Greece, Hong Kong, Honduras, Ireland, Israel, India, Italy, Iraq, Jordan, Japan, Korea, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Mexico, Morocco, Madagascar, Myanmar, Mauritius, Malaysia, Niger, Norway, New Zealand, Oman, Peru, Philippines, Pakistan, Poland, Potugal, Russia, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, Uzbekistan, South Africa and the Netherlands.
  • Description du dispositif
    e.cam Emission Imaging Computed Tomography Systems used for all common nuclear medicine procedures; 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