Events

Rappel de BladderScan BVI 9600 with AortaScan mode portable ultrasound instrument

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Verathon Medical Australia Pty Ltd.

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
    RC-2015-RN-01212-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-12-11
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01212-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notes supplémentaires dans les données
  • Cause
    The device is currently indicated for obtaining an image of the abdominal aorta for aortic diameter measurement. due to the design characteristics, the abdominal aortic measurement (aaa) reported by the device may be significantly smaller (or larger) than the actual diameter of the abdominal aorta. the devices can measure abdominal aortic diameters ranging from 3 to 12.4 cm with a diameter accuracy of ± 15% ± 0.5 cm. for example, a true abdominal aortic diameter of 5.3 cm may be reported to be as low as 4.01 cm or as large as 6.60 cm. in another example, a true abdominal aortic diameter of 3.5 cm may be reported to be as low as 2.48 cm or as large as 4.53 cm.Serious injuries and/or deaths could occur due to the failure mode associated with the issue. verathon have received a report of one (1) serious injury due to this issue.
  • Action
    The updated Operations and Maintenance Manuals clarify that these devices should not be used for the screening, detection, or diagnosis of AAAs. Because of the potential variation in measurement and the serious health risks associated with undetected AAAs, Verathon is reminding users that, if clinically indicated, appropriate patients should be referred for a diagnostic standard test for either screening for or diagnosis of an AAA regardless of test results obtained with BladderScan BVI 9600 device. This action has been closed-out on 24/08/2016.

Device

BladderScan BVI 9600 with AortaScan mode portable ultrasound instrument
  • Modèle / numéro de série
    BladderScan BVI 9600 with AortaScan mode portable ultrasound instrumentPart number: 0270-0452All Serial Numbers are affectedARTG Number: 165358
  • Classification du dispositif
    Radiology Devices
  • Manufacturer
    Verathon Medical Australia Pty Ltd

Manufacturer

Verathon Medical Australia Pty Ltd