Events

Rappel de Nexframe Stereotactic

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 Medtronic Image Guided Neurologics, 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
    45912
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0849-2008
  • Date de mise en oeuvre de l'événement
    2007-10-04
  • Date de publication de l'événement
    2008-02-07
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-07-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66464
  • 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
    Stereotaxic instrument - Product Code HAW
  • Cause
    Sterilty (package integrity) compromised: some failures were for damage to the outer pouch, while another set of failures were for the seals on this pouch. the seal between the inner tray and lid has not been compromised and the contents remain sterile, however, the sterility of the outer surfaces of the inner tray and lid cannot be assured.
  • Action
    On 10/4/2007, consignees were notified by Medtronic field personnel, either by personal visits or telephone. All wholesalers of this product are OUS. Medtronic OUS Regulatory personnel communicated this issue directly to the wholesalers, who provided the letters to their customers. Medtronic field personnel are responsible for completing and returning reply cards confirming all notifications (100%).

Device

Nexframe Stereotactic
  • Modèle / numéro de série
    Lot #s: 070380, 061248, 070175, 070375, 070621, 070825, 070634, 6510106A, 046510106A, 46515606, 046520506A, 046521606A, 046523406A,  61262, 70160, 070326, 070171, 60215, 070719, 070378, 070169, 070320, 70543, 070172, 610127, 610133, 70169, 61208, 70313, 51067, 60174, 60215 60578, 046510106C, 70153, 60175, 046510106F, 46534905, 046520506B, 070164, 070633, 070376, 070375, 070538, 070724, 070376, 61264, 61212,  070855, 070854, 070830, 070863, 070726, 070628, 60542, 60573, 60574, 60659, 61262, 70312, 070379, 61216, 70312, 070628, 070726, 61264, 070723 070166, 070629, 070164, 070379, 070856, 60583, 61237, 61238, 606110, 70312, 070159, 70174, 70144, 070160, 70375, 070631, 070825, 070726, 070628, 070863, 61208, 70145, 610134, 70321, 61247, 70315, 70334, 070724 070720, 070602, 070326, 070602, 070631, 070325, 070719, 70123, 70160,  046502607B, 070165, 070826, 046505707B, 60434, 60433, 046510106E
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide, USA, Taiwan, Thailand, Japan, Spain, Sweden and The Netherlands.
  • Description du dispositif
    Nexframe¿ Stereotactic System Kits, Model Number(s): DB-1021-MR, DB-1031, DB-1040-BL, DB-1040-ST, DB-1041, || DB-1041-BL, DB-1041-ST, DB-1042, DB-1042-BL, DB-1042-ST, || DB-1043, DB-1043-BL, DB-1043-ST, DB-2031, DB-2040-BL, || DB-2040-ST, DB-2041, DB-2041-BL, DB-2041-ST, DB-2042, || DB-2042-BL, DB-2042-ST, DB-2043, DB-2043-BL, DB-2043-ST,, Medtronic, Inc, Minneapolis, Minnesota
  • Manufacturer
    Medtronic Image Guided Neurologics, Inc.

Manufacturer

Medtronic Image Guided Neurologics, Inc.
  • Adresse du fabricant
    Medtronic Image Guided Neurologics, Inc., 2290 W Eau Gallie Blvd, Melbourne FL 32935-3133
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA