Events

Rappel de Symbia S Series SPECT 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..

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
    60142
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0283-2012
  • Date de mise en oeuvre de l'événement
    2011-10-14
  • Date de publication de l'événement
    2011-11-23
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-10-16
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104521
  • 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
    Single-Photon Emission Computed Tomography and Computed Tomography - Product Code KPS
  • Cause
    Errors could potentially impact image interpretation. the acquisition software is exhibiting a defect in the energy window position when an isotope is peaked. there is a potential patient safety issue when running syngo mi applications version va60a with foresight detectors firmware version v1.5.9.12 on the symbia systems.
  • Action
    Siemens Medical Solutions USA, Inc. sent an "Urgent Field Correction Recall" letter dated October 14, 2011 to all affected customers. The letters informed customers of the acquisition software defect in the energy window position when an isotope is peaked, which could potentially impact image interpretation, and that the AEB firmware version on their imaging system has been changed to a previously released version until acquisition software service pack is available. For questions or assistance they were instructed to contact Siemens Medical Solutions USA, Inc. at (800) 888-7436.

Device

Symbia S Series SPECT System
  • Modèle / numéro de série
    Symbia S Series systems, serial numbers 1236 and 1555, both with syngo MI Applications version VA60A and Foresight Detector AEB firmware version v1.5.9.12
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Florida, Illinois and Texas
  • Description du dispositif
    Siemens Medical Solutions USA, Inc., Symbia S Series SPECT System; Single-Photon Emission Computed Tomography. Indications for use: SPECT + CT: Perform scans and nuclear imaging studies with the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patient's anatomy.
  • Manufacturer
    Siemens Medical Solutions USA, Inc.

Manufacturer

Siemens Medical Solutions USA, Inc.
  • Adresse du fabricant
    Siemens Medical Solutions USA, Inc., 2501 Barrington Rd, Hoffman Estates IL 60195-2061
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    USFDA