Events

Rappel de Device Recall ECAT ACCEL

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
    45154
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0269-2008
  • Date de mise en oeuvre de l'événement
    2007-07-23
  • Date de publication de l'événement
    2007-11-29
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2009-09-11
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64980
  • 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
    Tomography Computed Emission System - Product Code KPS
  • Cause
    Incorrect decay correction results - ecat system's software versions 7.2.2 and 7.4 calculate the decay correction for emission data incorrectly, while performing whole-body studies with all transmissions followed by all emissions.
  • Action
    Siemans sent an Urgent Device Correction letter, dated June 15, 2007, to all affected consignees informing the user of the problem and requesting that they discontinue the practice of running all transmissions followed by all emissions until a corrective software patch is installed. The corrective software patch is expected to be installed by October 2007.

Device

Device Recall ECAT ACCEL
  • Modèle / numéro de série
    Serial Numbers: 101014, 1303, 1305, 1309, 1310, 1311, 1314, 301089, 301092, 301111, 3600211-00-001003, 3600211-00-001041, 3600211-00-001110, 3600211-00-001122, 3600211-00-0101001, 3600211-00-0101004, 3600211-00-0101005, 3600211-00-0101006, 3600211-00-0101008, 3600211-00-0101012, 3600211-00-0101015, 3600211-00-0101016, 3600211-00-0101017, 3600211-00-0201007, 3600211-00-0201022, 3600211-00-0201023, 3600211-00-0201024, 3600211-00-0201025, 3600211-00-0201026, 3600211-00-0201027, 3600211-00-0201029, 3600211-00-0201031, 3600211-00-0201032, 3600211-00-0201033, 3600211-00-0201035, 3600211-00-0201036, 3600211-00-0201037, 3600211-00-0201038, 3600211-00-0201039, 3600211-00-0201040, 3600211-00-0201041, 3600211-00-0201042, 3600211-00-0201043, 3600211-00-0201045, 3600211-00-0201049, 3600211-00-0201050, 3600211-00-0201051, 3600211-00-0201052, 3600211-00-0201053, 3600211-00-0201054, 3600211-00-0201055, 3600211-00-0201056, 3600211-00-0201057, 3600211-00-0201058, 3600211-00-0201060, 3600211-00-0201061, 3600211-00-0201062, 3600211-00-0201063, 3600211-00-0201064, 3600211-00-0201065, 3600211-00-0201066, 3600211-00-0201067, 3600211-00-0201069, 3600211-00-0201070, 3600211-00-0201071, 3600211-00-0201072, 3600211-00-0201079, 3600211-00-0201080, 3600211-00-0201084, 3600211-00-0201090, 3600211-00-0201091, 3600211-00-0201093, 3600211-00-0201095, 3600211-00-0201103, 3600211-00-0201104, 3600211-00-0201106, 3600211-00-0201115, 3600211-00-0201120, 3600211-00-0301073, 3600211-00-0301075, 3600211-00-0301076, 3600211-00-0301077, 3600211-00-0301078, 3600211-00-0301083, 3600211-00-0301085, 3600211-00-0301086, 3600211-00-0301087, 3600211-00-0301094, 3600211-00-0301096, 3600211-00-0301098, 3600211-00-0301099, 3600211-00-0301100, 3600211-00-0301102, 3600211-00-0301107, 3600211-00-0301108, 3600211-00-0301109, 3600211-00-0401112, 3600211-00-0401113, 3600211-00-0401114, 3600211-00-0401116, 3600211-00-0401117, 3600211-00-201034, 3600211-00-201046, 3600211-00-301097, 3600211-00-301105, 401118
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA and Countries of Argentina, Austria, Belgium, Brazil, Canada, Switzerland, Chile, China, Czech Republic, Germany, Denmark, Spain, Finland, France, Great Britain, Italy, Japan, South Korea, Netherlands, Norway, Saudi Arabia, Sweden, Slovak Republic, Turkey, and Taiwan.
  • Description du dispositif
    Siemens ECAT ACCEL, Catalog No. 3554479, PET/CT Scanner, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534
  • 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
  • Source
    USFDA