Events

Rappel de Device Recall PRIMUS, ONCOR, ARTISTE Linac systems

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
    65848
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2095-2013
  • Date de mise en oeuvre de l'événement
    2013-07-18
  • Date de publication de l'événement
    2013-08-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-11-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120525
  • 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 customer complaint concerning the rail threaded holes of the 550txt treatment tabletop. due to a manufacturing error, the screws holding the side rails in position on the tabletop might break off.
  • Action
    Siemens released Updated Instruction containing the Medical Device Correction Field Safety Notice of Improvement letter, which was delivered by the Siemens Customer Service Group to all affected customers. The release of this UI TH002/12/S to distribute the update instruction began on July 18, 2013. This document includes completion protocol, which will be completed at each facility and returned to Siemens. A copy of the notification should be kept in the Digital Linear Accelerator System owners manual under Safety Advisory letters. UPDATE: a secnd update intruction, TH003/12/S has been released to begin the replcement of tabletops identified through the inspection carried out through TH002/12/S.

Device

Device Recall PRIMUS, ONCOR, ARTISTE Linac systems
  • Modèle / numéro de série
    ONCOR, PRIMUS and ARTISTE Lican systems with tabletop component: Tabletop, 550TxT, TT-A 08632296* Tabletop, 550TxT, TT-S 10046140
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide in the states of NJ, IN, PA, FL, OH, MN, MO, CA, AL, NE MI, LA. and countries of:Argentina, China, South Africa, Pakistan, Spain, Switzerland, Italy, Algeria, Croatia, Turkey, Canada, Germany, France, Poland, Japan, Russian Federation. Lebanon, Egypt, Slovakia, Latvia, Kenya, Brazil, Kuwait, Saudi Arabia, Greece, Belgium, Taiwan, Portugal.
  • Description du dispositif
    PRIMUS, ONCOR, ARTISTE Linac systems with component Tabletop, 550TxT, TT-A s/n 1001-1233 and Tabletop 550TxT, TT-S s/n 1001-1083. || Product Usage: The intended use of the SIEMENS branded, ARTISTE, ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Adresse du fabricant
    Siemens Medical Solutions USA, Inc, 757 Arnold Dr Ste A, Martinez CA 94553-3615
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    USFDA