Events

Rappel de Device Recall camera imaging system

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 - Radiation Oncology.

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
    58813
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2640-2011
  • Date de mise en oeuvre de l'événement
    2010-11-04
  • Date de publication de l'événement
    2011-06-23
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-11-14
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100354
  • 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
    The firm has become aware of a potential issue that may result in a service engineer receiving an electrical shock should the connector cable housing become unfastened from the chassis.
  • Action
    The firm, SIEMENS, sent a "Customer Information" letter to its customers on November 4, 2010. The letter describes the product, problem and actions to be taken. The customers were instructed to include this letter in their BEAMVIEW TI System Owner Manual chapter "Safety Advisory Letters" where it should remain. Siemens has developed an updated kit to install an additional grounding cable on the camera's central control unit to eliminate the problem. The updated kit was delivered with the Customer Information letter. If you have any questions, contact the Service Manager- Regulatory Affairs at 925-246-8407.

Device

Device Recall camera imaging system
  • Modèle / numéro de série
    All units of the part number: 1940035
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution:
  • Description du dispositif
    MEV ATRON M2/PRIMUS MID-ENERGY, camera imaging system, Part Number: 1940035; Product is manufactured and distributed by SIEMENS MEDICAL SOLUTIONS USA, INC. Concord, CA; and SIEMENS AG, MEDICAL SOLUTIONS || Roentgenstrasse, Kemnath, GERMANY, and SIEMENS AG, MEDICAL SOLUTIONS || Henkestrasse, Erlangen, GERMANY || The intended use of the SIEMENS branded linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
  • Manufacturer
    Siemens Medical Solutions USA, Inc - Radiation Oncology

Manufacturer

Siemens Medical Solutions USA, Inc - Radiation Oncology
  • Adresse du fabricant
    Siemens Medical Solutions USA, Inc - Radiation Oncology, 4040 Nelson Ave, Concord CA 94520-1200
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    USFDA