Device Recall Verathon BladderScan BVI 9400

  • Modèle / numéro de série
    Units with serial numbers ranging from 1000 to 3179 are affected. (Serial number 1564 was not used.) The serial number is assigned as a sequential number, with no breakdown.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide - US, Canada, Malaysia, Hong Kong, Singapore, Argentina, New Zealand, Barbados, Dominican Republic, and Costa Rica.
  • Description du dispositif
    The BladderScan BVI 9400 is a portable ultrasound instrument that provides a noninvasive measurement of urinary bladder volume. The device consists of an ultrasound probe that scans the patient's bladder, and a battery operated console that provides measurement related information. The BVI 9400 measures ultrasonic reflections on multiple planes inside the body and produces a three dimensional image. Based on the image, the BVI 9400 calculates and displays bladder volume.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Verathon, Inc., 20001 N Creek Pkwy, Bothell WA 98011-8218
  • Société-mère du fabricant (2017)
  • Source
    USFDA