Device Recall Medtronic Oarm Imaging System

  • Modèle / numéro de série
    Serial Numbers: 109R, 118R, 124, 136, 159 ,170, 218, 222, 223, 236, 239 , 299, 309R, 402, 410, 412, 414.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA, including the states of AL, CO, FL, IA, MI, IA, NC, NE, NY and the countries of South Africa, Italy, and Spain.
  • Description du dispositif
    Medtronic O-arm¿ Imaging System. Product Numbers: BI-700-00027-100, BI-700-00027-100R, BI-700-00027-120, BI-700-00027-120R, BI-700-00027-230, BI-700-00027-230R.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Medtronic Navigation, Inc., 300 Foster St, Littleton MA 01460-2017
  • 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

Un dispositif médical avec un nom similaire

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  • Modèle / numéro de série
    Model No. BI-700-00027 and BI-700-00028 Serial number range: 00102 through 00753 and B13080721, B13080722, B13090729, B13120763, B13120764, B13120766, B13120768, B13120769
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    USA (nationwide) Distribution
  • Description du dispositif
    Medtronic O-arm Imaging System Mobile X-ray system. || Model No. BI-700-00027 and BI-700-00028 || The 0-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The 0-ann Imaging System is compatible with certain Image Guided Surgery Systems.
  • Manufacturer