Events

Rappel de Device Recall Linear Accelerator

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
    59122
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-3003-2011
  • Date de mise en oeuvre de l'événement
    2011-06-03
  • Date de publication de l'événement
    2011-08-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-02-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=101290
  • 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
    Accelerator, linear, medical - Product Code IYE
  • Cause
    A potential safety issue was discovered when a pause for an imaging segment is inserted (where an imaging segment does not exist) with the artiste and rt therapist 4.1 system will continue to the next image.
  • Action
    Siemens sent an "Urgent: Medical Device Correction/ Customer Safety Advisory Notice" letter to all affected customers starting June 3, 2011. The letter describes the product, problem, and instructions to prevent mistreatment. The letter states that Siemens is working on an updated version of RTT 4.1 that will fix the issues. Users will be notified as soon as the update for the system is available. The customers were instructed to include Customer Safety Advisory notice in their syngo RT Therapist 4.1 System Owner Manual chapter "Safety Advisory Letters" where it should remain.

Device

Device Recall Linear Accelerator
  • Modèle / numéro de série
    Therapist Express Basic, Part Number 08151289; Therapist Express Assist, Part Number 08151297; syngo RT Therapist Assist, Part Number 08162807; syngo RT Therapist, Part Number 08162815; syngo RT Therapist Connect/MOSIAQ OIS, Part Number 08168754.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) including the states of: DE, FL, KY, LA, MA, MI, MO, NE, NJ, OH, PA, TN, WI, UT, WV and Puerto Rico and the countries of: Australia, Belgium, Brazil, Canada, China, Egypt, France, Germany, Hungary, India, Ireland, Italy, Lebanon, Malaysia, Netherlands, New Zealand, Philippines, Poland, Republic of Korea, Russian Fed, Saudi Arabia, South Africa, Norway, Spain, Turkey and United Kingdom.
  • Description du dispositif
    ARTISTE Linear Accelerator with RT Therapist v4.1 system. || Siemens Medical Solutions, Kemnath, Germany. || Distributed by Siemens Medical Solutions, Concord, CA 94520. || Product Usage: Linear Accelerators used to deliver X-ray photon and electron radiation for therapeutic treatment of cancer.
  • 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