Events

Rappel de Device Recall Acuson X300

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
    53209
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2065-2011
  • Date de mise en oeuvre de l'événement
    2009-07-30
  • Date de publication de l'événement
    2011-04-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-04-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84981
  • 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, imaging, pulsed doppler, ultrasonic - Product Code IYN
  • Cause
    Software error with potential for misinterpretation of data-- the previous patient's last capture clip image can appear in the next patient's study.
  • Action
    The firm, Siemens, sent a "CUSTOMER SAFETY ADVISORY NOTIFICATION" letter to its customers on July 30, 2009. The letter described the product, problem and actions to be taken. The customers were instructed they need to update any of the patient registration settings to reset the cine buffer so that no data is transferred between studies, if the system software is not being updated. Siemens informed the customers that a mandatory update software is being installed on their system free of charge. If you have any questions, contact (650) 969-9112.

Device

Device Recall Acuson X300
  • Modèle / numéro de série
    Serial numbers
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries including: Albania, algeria, Argentina, Australia, Austria, Azerbaijan, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile,China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Greece, Hungary, India, Indonesia, Iran, Ireland, Italy, Japan, Kazakhstan, Kenya, Kosovo, Lativia, Lithuania, Luxembourg, New, Zealand, Nicaragua, Norway, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam.
  • Description du dispositif
    Acuson X300 systems at software versions 1.00.00 to 1.0.10 and 2.0.00 to 2.0.02, model numbers 10037409, 10132987, and 10038837, manufactured by Siemens Medical Solutions ultrasound business unit, Mountain View, CA || Medical device is an ultrasound imaging system for general radiology, fetal, abdominal, intraoperative, pediatric, small parts, neonatal/adult cephalic, cardiac, transesophageal, pelvic, transcranial, ob/gyn, urology, vascular, musculoskeletal, superficial musculoskeletal and peripheral vascular applications. The system also provides for measurements of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
  • Manufacturer
    Siemens Medical Solutions USA, Inc.

Manufacturer

Siemens Medical Solutions USA, Inc.
  • Adresse du fabricant
    Siemens Medical Solutions USA, Inc., 1230 Shorebird Way, P.O. Box 7393, Mountain View CA 94043
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    USFDA