Events

Rappel de Device Recall ACUSON Sequoia 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
    53013
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2115-2011
  • Date de mise en oeuvre de l'événement
    2009-05-15
  • Date de publication de l'événement
    2011-04-29
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-04-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84459
  • 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
    Shock hazard. the manufacturer failed to set the system power switch to "on" during the line level leakage and high pot current draw testing.
  • Action
    Siemens Medical Solutions USA, Inc. sent a Customer Safety Advisory Notification letter out on May 15, 2009. Service engineers were to visit each customer to conduct necessary testing. For questions regarding this recall call 650-694-5993.

Device

Device Recall ACUSON Sequoia System
  • Modèle / numéro de série
    Serial numbers: 66214, 69268, 69302, and 69356.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including CA, IL, MD, NC, OH, and UT and the countries of Australia, China, Denmark, Spain, South Korea, Norway, Poland, Russia and Sweden.
  • Description du dispositif
    ACUSON Sequoia C512/512SS Adv PE 10.0 System, model number 10041127. Distributed by Siemens Medical Solutions USA, Inc., Business Unit Ultrasound, Mountain View, CA. || The ACUSON Sequoia is a general purpose Diagnostic Ultrasound system. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in: B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, Harmonic Imaging or 3D imaging on a FPD Display. The ACUSON Sequoia is intended for the following applications: Abdominal, General Imaging and Cardiolgoy for Fetal, Abdominal, Intraoperative (abdominal and neurological), Pediatrics, Small Organs (breat, testes, thyroid and penis), Neonatal/Adult Cephalic, Cardiac (adult, pediatric and neonatal), Transesophageal, Transrectal, Transvaginal, Peripheral Vessels and Musculo-sceletal (superficial and conventional) applications. The system also provides for the measurement of anatomical structures 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