Events

Rappel de Device Recall Primus

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-1758-2008
  • 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=69072
  • 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
  • Modèle / numéro de série
    Serial numbers: 3061 3986 2469 2476 2443 2455 2549 2719 2728 2772 2795 2821 2925 2999 3056 3083 3088 3169 3282 3325 3429 3432 3472 3538 3555 3563 3593 3633 3637 3682 3685 3726 3971 4007 5055 3923 2707 3321, and  2449
  • 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, Mevatron M2/ Primus Mid Digital Linear Accelerator, part number 1940035 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