Events

Rappel de c.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
    37857
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0906-2007
  • Date de mise en oeuvre de l'événement
    2007-04-30
  • Date de publication de l'événement
    2007-06-06
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2009-01-09
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51963
  • 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
    Tomography System (Emission Computed) - Product Code KPS
  • Cause
    Chair breakage: under extreme load, the chair back of the c.Cam emission computed tomography system may bend and eventually break. this could be caused by the accumulated stress from heavy patients seating or stretching themselves in the chair or simply from long time use.
  • Action
    Important Safety Notice letters dated 4/30/07 on Siemens letterhead were sent to the end users, informing them of the potential risk that the c.cam chair may bend or break under heavy load. They were told that a Siemens service representative will contact them within the next few days to arrange the repair of the chair at no cost to the end user. To ensure the chair does not become damaged, SIemens recommended that the c.cam not be used for patient scanning until the update has been performed on the chair. Any questions regarding the Important Safety Notice were directed to their service representative or Siemens' office at: 1-800-888-7436 (USA).

Device

c.cam
  • Modèle / numéro de série
    Model 9VIR1200, serial numbers 1001 thru 1243, 1245 thru 1263, 1265 thru 1283, 1285 thru 1303, 1305 thru 1316, 1320, 1321, 1322, 1323, 1325 thru 1343, 1345 thru 1363, 1365 thru 1383, 1385 thru 1403, 1405 thru 1422, 1507, 1508, 1509.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide-USA, Canada, France, Germany, Israel, The Netherlands and Portugal.
  • Description du dispositif
    c.cam Gamma Camera, Model 9VIR1200; Siemens Medical Solutions USA, Inc., Molecular Imaging, 2501 N. Barrington Road, Hoffman Estates, IL 60195-5203; Made in Denmark;
  • Manufacturer
    Siemens Medical Solutions USA, Inc.

Manufacturer

Siemens Medical Solutions USA, Inc.
  • Adresse du fabricant
    Siemens Medical Solutions USA, Inc., 2501 Barrington Rd, Hoffman Estates IL 60195-2061
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    USFDA