Events

Rappel de Device Recall PRIMUS Plus

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
    47226
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1759-2008
  • Date de mise en oeuvre de l'événement
    2007-12-10
  • Date de publication de l'événement
    2008-09-29
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-05-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69073
  • 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
    Linear Accelerator - Product Code IYE
  • Cause
    Radiation leak: when used with field sizes of 5cm x 5cm or smaller, product may leak radiation at a distance of 2 cm from the side of the applicator body up to 13%, in excess of iec standards.
  • Action
    Siemens sent a Customer Safety Advisory Notice dated 12/12/2007 to DEVA customers. The letter stated that Siemens would temporarily disable energies 5MeV and below for all customers that decide to continue using the DEVA, resulting in the temporary unavailability of energies 5MeV and below for all available. Customers wishing not to have these energies blocked must return their DEVA and they would be contacted by a local Siemens rep to schedule a service appointment. The letter stated that as a preventative measure that those customers should refrain from using the DEVA with any combination of energies 5MeV and below with field sizes smaller than 6cm x 6cm. The firm suggested using the fixed field electron applicators and cutouts with these energies and field sizes. Siemens will release a new control console software in 2008 for free-of-charge, that will limit the use of the DEVA to energies 6MeV and above, while allowing the use of lower energies using the fixed field electron applicatiors.

Device

Device Recall PRIMUS Plus
  • Modèle / numéro de série
    Serial Numbers:3174 3241 3254 2938 3193 3359 3488 3529 3536 3717 3813 3844 3876 3985 3991 4033 4047 2782 2783 2785 2797 2815 2832 2862 2878 2904 2916 2918 2922 2942 2964 2973 2979 2989 2992 2993 2994 3007 3031 3043 3044 3046 3106 3117 3144 3183 3234 3242 3249 3262 3278 3284 3299 3308 3326 3334 3373 3389 3396 3408 3421 3431 3438 3455 3475 3481 3531 3561 3594 3632 3642 3689 3724 3728 3762 3767 3782 3814 3833 3867 3915 4004 4045 4051 4131 4232 5007 3431 3158 3216 3356, and  3619
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: USA, Canada, Belgium, Bulgaria, France, Germany, Hungary, India, Italy, Japan, Malaysia, P.R. China, Pakistan, Poland, Portugal, Qatar, Republic Korea, South Africa, Spain, Sweden, and United Kingdom.
  • Description du dispositif
    Siemens Medical Solutions, PRIMUS Plus Digital Linear Accelerator, part number 4504200 equipped with a Digital Electron Variable Applicator (DEVA, Part Number 8485971) with available energy of 6 MeV.
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Adresse du fabricant
    Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concord CA 94520-1200
  • Source
    USFDA