Events

Rappel de Device Recall InstaTrak 3500 Plus

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 GE OEC 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
    37661
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0181-2008
  • Date de mise en oeuvre de l'événement
    2007-03-23
  • Date de publication de l'événement
    2007-11-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-04-16
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51247
  • 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
    Image Processing Radiological System - Product Code LLZ
  • Cause
    Tracking accuracy - image intensifier supplier's change on the c-arm could lead to patient injury, due to incorrect anatomical location of the instrument during a procedure.
  • Action
    Consignees were sent an Urgent Recall Notice letter, via mail dated 10/11/07, advising users to stop usage of the FluoroTrak and FluoroCAT spinal applications on the InstaTrak 3500 Plus System. Once a solution is identified, a representative will contact consignees to arrange for installation of the solution at no charge.

Device

Device Recall InstaTrak 3500 Plus
  • Modèle / numéro de série
    Serial numbers: IT35052, IT35070, IT35108, IT35109, IT35129, IT35130, IT35132, IT35133, IT35134, IT35139, IT35146, IT35152, IT35166, IT35169P-RC-1, IT35173, IT35179P, IT35181, IT35185P-G-RC, IT35187P, IT35189P, IT35193P, IT35214P, IT35216P, IT35223P, IT35225P, IT35226P, IT35234P, IT35244P, IT35245P, IT35251P, IT35269P, IT35280P, IT35286P, IT35289P, IT35292P, IT35293P, IT35296P, IT35299P, IT35301P, IT35302P, IT35304P, IT35311P, IT35312P, IT35316P, IT35323P, IT35324P, IT35330P, IT35339P, IT35344P, IT35375P, IT35377P, IT35379P, IT35381P, IT35382P, IT35383P, IT35406G, IT35435G, IT35458G, IT35468G.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Class II Recall - Worldwide Distribution - USA including states of AZ, CA, FL, GA, IA, IL, KS, LA, MA, MD, MI, NC, NY, OK, PA, SC, TX, UT, VA, and WI, and countries of Canada, China, Germany, Hong Kong, Italy, Japan, Mexico, and Spain.
  • Description du dispositif
    GE OEC, InstaTrak 3500 Plus FluoroTrak and Fluoro CAT Spinal Applications used with Regular and Super 9800 and 9600 Arm Systems. GE Health Medical Systems, Inc, Salt Lake City, UT 84116-2862
  • Manufacturer
    GE OEC Medical Systems, Inc

Manufacturer

GE OEC Medical Systems, Inc
  • Adresse du fabricant
    GE OEC Medical Systems, Inc, 384 Wright Brothers Dr, Salt Lake City UT 84116-2862
  • Source
    USFDA