Events

Recall of BladderScan BVI 9600 with AortaScan mode portable ultrasound instrument

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Verathon Medical Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2015-RN-01212-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-12-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01212-1
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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

Manufacturer

Verathon Medical Australia Pty Ltd