Events

Rappel de Device Recall Ingenia 3.0T R5

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 Philips Medical Systems, 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
    68588
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1862-2014
  • Date de mise en oeuvre de l'événement
    2014-06-13
  • Date de publication de l'événement
    2014-06-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-01-27
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128275
  • 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
    For some identified ingenia systems shipped between december 2013 and march 2014, cover set rear magnetic m10 nuts were erroneously supplied instead of a4 stainless steel nuts.
  • Action
    On June 14, 2014, Field Safety Notice (FSN 78100432), was be sent to all US and Canadian consignees via certified mail. Philips Key Market representatives will distribute the letter internationally. The FSN instructs consignees to not let hospital technical staff or any person other than Philips service engineers dismount the rear covers before the system is inspected and/or corrected by Philips. Philips has alerted installation and service engineers to this hazard. A Field Change Order with reference FCO781 00432 is being released directing Philips field service engineers to inspect the Ingenia rear cover set nuts and replace them if needed with non-magnetic stainless steel nuts. For further information or support concerning this issue, consignees should contact their local Philips representative at 1-800-722-9377.

Device

Device Recall Ingenia 3.0T R5
  • Modèle / numéro de série
    Model Numbers: 781342
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including the states of AL, AZ, CA, CO, GA, ME, MI, NY, OH, PA, TX, and WA, and the countries of Mexico, Argentina, Australia, Belarus, Belgium, Brazil, Chile, China, France, Germany, Hong Kong, India, Indonesia, Ireland, Italy, Japan, South Korea, Laos, New Zealand, Norway, Palau, Poland, Portugal, Qatar, South Africa, Sweden, Switzerland, Taiwan, Tunisia, Turkey, Turkey, United Kingdom, Venezuela, and Vietnam.
  • Description du dispositif
    Ingenia 3.0T R5, magnetic resonance imaging system.
  • Manufacturer
    Philips Medical Systems, Inc.

Manufacturer

Philips Medical Systems, Inc.
  • Adresse du fabricant
    Philips Medical Systems, Inc., 3000 Minuteman Rd, Andover MA 01810-1032
  • Société-mère du fabricant (2017)
    Philips
  • Source
    USFDA