BIOPSY NEEDLE KIT

  • Modèle / numéro de série
    Lot No.: 66516213 66501413 66518413 66507713
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    BIOPSY NEEDLE KIT, 9733068, PASSIVE
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Medtronic Navigation, Inc., 826 Coal Creek Cir, Louisville CO 80027-9710
  • Société-mère du fabricant (2017)
  • 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

5 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    Model: Part Number: 9733068, 9733065, 9733066, Affected: 4 lots, 5 lots, 6 lots respectively
  • Manufacturer
  • Modèle / numéro de série
  • Manufacturer
  • Modèle / numéro de série
    LOT No: 066503515, 066504315, 066506515
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) and Canada.
  • Description du dispositif
    Medtronic Passive Biopsy Needle Kit, Part Number 9733068 - Passive Biopsy Needle Kit. || The image guided Passive Biopsy Needle is an accessory instrument with the StealthStation System. The Biopsy Needle is intended to be used for stereotaxy biopsy of brain tissue.
  • Manufacturer
  • Modèle / numéro de série
    LOT No: 0007525461. 0007599312
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) and Canada.
  • Description du dispositif
    Medtronic Passive Biopsy Needle Kit, Part Number 9731754 - Passive Biopsy Fee Per Use (FPU) Kit. || The image guided Passive Biopsy Needle is an accessory instrument with the StealthStation System. The Biopsy Needle is intended to be used for stereotaxy biopsy of brain tissue.
  • Manufacturer