Events

Rappel de Device Recall ARTISTE , ONCOR and PRIMUS accelerators

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
    58534
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2216-2011
  • Date de mise en oeuvre de l'événement
    2011-03-31
  • Date de publication de l'événement
    2011-05-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-03-30
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99531
  • 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
    Siemens has become aware of a potential safety issue that may result in mistreatment when customers are configured with the artiste linac rt therapist v4.2 in combination with rt oncologist v.4.2 and use the remote "online 2d image review.
  • Action
    The firm, Siemens, sent an "Urgent: Medical Device Correction Customer Safety Advisory Notice" on March 31, 2011 via Siemens Customer Service Group or certified mail to its customers. The notice describes the product, problem and actions to be taken. The customers were instructed to not use the "Online 2D Image Review" on the Syngo RT Oncologist 4.2; to always calculate the offset directly on the RTT 4.2 before it is applied for the treatment with the patient on the treatment table; include this notice in their syngo RT Therapist 4.2 System Owner Manual chapter "Safety Advisory Letter" where it should remain until the measures defined in the notice are performed, and in the interest of safety, perform the preventative measures noted in this notice and inform all affected personnel immediately. Siemens is currently working on a solution for the incremental loading workflow in syngo RT Therapist 4.2 and will provide a software update as soon as possible. Siemens will notify the customers as soon as an update for their system will be available. UPDATE: The release of Safety Update UI TH010/11/S to distribute the software update for RTTv4.2.94O04 began on April 15, 2011. If you have any questions, contact Regulatory Affairs at 925-602-8157.

Device

Device Recall ARTISTE , ONCOR and PRIMUS accelerators
  • Modèle / numéro de série
    Therapist Exoress Basis Part number 08515289 syngo Therapist Express Part Number 08162815 syngo RT Therapist Connect/ MOSAIQ OIS Part number 08168754.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including states of: CA, FL, OH, PA and UT; and countries including: Australia, Belgium, Croatia, Germany, Japan, South Africa, Sweden and United Kingdom.
  • Description du dispositif
    ARTISTE , ONCOR and PRIMUS accelerators that utilize the RT Therapist v4.2 system in combination with syngo RT Oncologist 4.2. || The ONCOR and PRIMUS may be updated to utilize the RT Therapist v4.2 software. The RT Oncologist v4.2 is currently only on Non-US systems. || Distributed by Siemens Healthcare, Concord, CA 94520 || Intended use: Radiation therapy
  • 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