Events

Rappel de Device Recall Verathon BladderScan BVI 9400

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 Verathon, 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
    52769
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1939-2009
  • Date de mise en oeuvre de l'événement
    2009-05-18
  • Date de publication de l'événement
    2009-09-17
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-10-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83963
  • 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
    Ultrasonic pulsed echo imaging system - Product Code IYO
  • Cause
    Three specific issues are being addressed: 1. calculation and use of an incorrect year in dates after 12/31/2009. 2. double scans, continuous scans, and double printing. 3. calibration sensitivity.
  • Action
    U.S. customers (including Government) were sent a post card on or about 5/18/2009 and were called about the upgrade. Units are to be upgraded by the customers using an online tool called ScanPoint. Customers may elect to return their units to the firm for upgrading. Canadian customers were phoned by Verathon. For foreign units sold and distributed through one of the recalling firm's related firms, Service Bulletin SB-0014 was sent to the distributors located in The Netherlands, United Kingdom, and Australia. Contact Verathon Customer Care at 1-800-331-2313 if you have any questions.

Device

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
    Radiology Devices
  • 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
    Verathon, Inc.

Manufacturer

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