Events

Rappel de Device Recall MAGNETOM Avanto, Espree, Trio A Tim 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
    58080
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2021-2011
  • Date de mise en oeuvre de l'événement
    2011-03-03
  • Date de publication de l'événement
    2011-04-18
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-12-09
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98281
  • 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 Nuclear Magnetic Resonance Imaging - Product Code LNH
  • Cause
    Firm discovered during product monitoring that on a few systems the gradient cable connections did not meet their specifications after installation. the potential exists for a cable connection to become overheated, leading to the emission of smoke and possible material damage.
  • Action
    Siemens Medical Solutions Inc., issued a Customer Safety Advisory Notice dated November 24, 2010, to affected customers via Update Instructions MR029/10S. Affected customers will be notified via hand delivered letter by Siemens Service Engineers at the time of inspection. A future Update instruction will be released for installation of detectors in appropriate locations on systems to switch off the power electronics in the event of a malfunction in the power supply of the gradient coils. Further questions regarding this recall please call (610) 448-3237.

Device

Device Recall MAGNETOM Avanto, Espree, Trio A Tim System
  • Modèle / numéro de série
    Model numbers 10018165, 10018221, 10018222, 7387074, 7391167. 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  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Product was distributed domestically to hospitals and imaging centers in the District of Columbia, Puerto Rico, AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WI, and WY(every State except VT).
  • Description du dispositif
    MAGNETOM Avanto, Espree, Trio A Tim System. || Nuclear magnetic resonance imaging.
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Adresse du fabricant
    Siemens Medical Solutions USA, Inc, 51 Valley Stream Pkwy, Malvern PA 19355
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    USFDA