Events

Rappel de Device Recall Siemens brand 550 TxT Patient Treatment Table

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
    55577
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2023-2011
  • Date de mise en oeuvre de l'événement
    2010-03-31
  • Date de publication de l'événement
    2011-04-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-03-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91174
  • 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
    Couch, radiation therapy, powered - Product Code JAI
  • Cause
    Potential for causing overheating of the power supply during treatment, and potential for unexpected table descent.
  • Action
    Siemens issued a Customer Information letter dated March 21, 2010. There were two safety issues. There were two occurrences of smoke caused by an overheating of the power supply during patient treatment. Also, there had been a report of an unexpected lowering of the 550TxT table in patient rescue mode. With the released kit that accompanies this letter, Siemens has implemented a minor modification on the 550TxT to include an additional fuse within the power supply circuit to address the first issue described above. They also included an additional modification to address the lowering of the table by the integration of additional relays. As soon as the "move enable" button is released, the table brake will be enabled which is controlled by the implemented relays. No further action is required for the continued operations of the 550TxT table. Further questions regarding this recall please call (925) 246-8407

Device

Device Recall Siemens brand 550 TxT Patient Treatment Table
  • Modèle / numéro de série
    All units of Listing Number: R864406
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- Including USA, states of NJ, WI, NY, and MA.
  • Description du dispositif
    Siemens brand 550 TxT Patient Treatment Table, part number 7346534; Product is manufactured and distributed by Siemens AG, Medical Solutions, Roentgenstrasse 19-21, Kemnath, Germany 95478. || The 550 TxT Treatment Table is to be used as an integral part of the Siemens linear accelerator systems to position the patient accurately according to the treatment plan for various radiation therapy treatment techniques.
  • 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