Events

Rappel de 4Z1c matrix array transducer

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
    57289
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0826-2011
  • Date de publication de l'événement
    2010-12-28
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-10-04
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95746
  • 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, ultlrasonic - Product Code IYN
  • Cause
    There is the possibility of a short occurring in the transducer which could cause focal heating on the probe face.
  • Action
    SIEMENS issued a filed correction in the form of a "Customer Safety Advisory Notification" initiated on September 29, 2010 and mailed to customers by Federal Express on the same day. The notification described the product, problem and actions to be taken by the customers. The customers were instructed to examine the 4Z1c transducer prior to use (Note: if transducer does not show a blister on its front face or does not feel unusually when it is safe for use); to immediately discontinue use and contact their local Siemens representative to get issue resolved, if the transducers developed a hot spot that exhibits a visible blister on the patient contact surface and feels hot to the touch during operation, and to pass this notice on to all those within their organization who need to be aware. If you have any questions, please contact (650) 969-9112 or (800) 422-8766.

Device

4Z1c matrix array transducer
  • Modèle / numéro de série
    Material number: 10433816: Serial numbers:  82638701 82741703 84254503 84355608 84455108 84754522 84857919 91861815 84858401 84655617 91654526 83044913 90261810 90864208 01288401 61101009 61601024 81631208 83146817 83251905 83751103 83752419 84455113 84557302 84753934 84857907 85056212 91503602 93771403 94982205 83650009 90656713 95183003 84456707 84153940 84857908 84857918 84953903 92068501 92256206 82540305 84053927 83853304 84656203 94065109
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: USA and countries including: Australia, Belgium, Brazil, China, Czech Republic, Finland, France, Germany, India, Ireland, Italy, Japan, Kenya, Malaysia, Netherlands, Norway, Portugal, South Korea, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates, United Kingdom.
  • Description du dispositif
    4Z1c matrix array transducer which is used with ACUSON SC2000 ultrasound system. || Siemens Medical Solutions USA, Inc. || Business Unit Ultrasound || 1230 Shorebird Way || Mountain View, CA 94043 || Intended use: 4Z1 transducer is a special purpose ultrasound transducer designed to help clinicians perform adult echocardiography and pre-operative and intra-operative surgical assessments. Secondary applications include: pediatric, echocardiography, primarily benefiting older and larger pediatric populations, general abdominal and Pinta-operative pediatric abdominal imaging and peripheral vessel imaging.
  • 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