Device Recall Philips Ingenia 1 .5T and Ingenia 3.OT MR systems

  • Modèle / numéro de série
    781437: 15001, 15002, 15003 781438: 30001, 30002, 30003, 30004, 30005, 30006
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -US including CA, NY and Internationally to United Kingdom, Australia, Norway, and Thailand
  • Description du dispositif
    Ingenia MR-OR; 781437, 781438 || The MR-OR option is intended for allowing transfer of a neurosurgical patient from OR suite to MR suite and back with tools and instructions for proper positioning and MR imaging of those patients. MR-OR option also facilitates execution of simple neurosurgical procedures in the near proximity of the MR scanner without a need to move the patient back to the OR suite
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Philips Electronics North America Corporation, 3000 Minuteman Rd, Andover MA 01810-1032
  • Société-mère du fabricant (2017)
  • Source
    USFDA