Events

Rappel de Device Recall Biograph mCT S(40)4R

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
    76127
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0995-2017
  • Date de mise en oeuvre de l'événement
    2016-12-13
  • Date de publication de l'événement
    2017-01-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-05-08
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152236
  • 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
    System, tomography, computed, emission - Product Code KPS
  • Cause
    Siemens medical solutions, molecular imaging has become aware, through our supplier that some laser cover windows may fall off.
  • Action
    Siemens Healthineers sent a Customer Safety Advisory Notice letter on December 13, 2016. The letter states that the light marker windows used for the positioning laser and integrated into the front cover of the Biograph mCT or Biograph mCT Flow system may loosen and potentially drop out and warning the consignee not to use the system of the front cover is loose or missing. Customers with questions were instructed to contact their local Siemens representative at the following numbers: America 1-800-888-7436 Europe, Middle East and Africa +49 9131 940 4000 Asia and Australia +86 (21) 3811 2121 For questions regarding this recall call 865-218-2000.

Device

Device Recall Biograph mCT S(40)4R
  • Modèle / numéro de série
    Serial Numbers: 11043, 11045, 11046, 11072, 11058, 11069, 1013, 11081, 11057, 1002, 1008, 1011, 1019, 11037, 11040, 11067, 11073, 1003, 1007, 1017, 11029, 11032, 11051, 11054, 11061, 11062, 11063, 11080, 11053, 1001, 11077, 1025, 11033, 11049, 11084, 21087, 21091, 1012, 1014, 11039, 11055, 11056, 11059, 11075, 11078, 21085, 21089, 21090, 1018, 11036, 1005, 11038, 11047, 11064, 11065, 21086, 11031, 11028, 11070, 1020, 11068, 11026, 21088, 1006, 1004, 1009, 1010, 1016, 1015, 1022, 1023, 1024, 11027, 11034, 11035, 11041, 11042, 11048, 11050, 11052, 11060, 11066, 11071, 11074, 11076, 11082, 11083
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) and Internationally to U.A.E., AT, AU, AZ, BR, CA, ,CH, CL, CN, CO, CZ, DE, DK, EG,FI, FR, GB, HK, HR, IL, IN, IR, IT, JP, KR, MX, NL, NO, NZ, PK, PL, QA, RO RU, SE, SG, SI, SK, TH, TR, AND TW.
  • Description du dispositif
    Biograph mCT S(40)-4R, Material Number 10248671 || The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for the fused PET and CT images. The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and / or PET diagnostic imaging. These systems are intended to be utilized by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.
  • Manufacturer
    Siemens Medical Solutions USA Inc.

Manufacturer

Siemens Medical Solutions USA Inc.
  • Adresse du fabricant
    Siemens Medical Solutions USA Inc., 810 Innovation Dr, Knoxville TN 37932-2562
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    USFDA