Verathon, Inc. recalls BladderScan BVI 9600, Model Numbers: 0270-0451, 0270-0452, 0270-0754, and U270-0451. AortaScan AMI 9700, Model Numbers:…

Recall date

November 30, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1091-2016

FDA classification

Class II

Brand / firm

Verathon, Inc.

Sold / distributed

Worldwide Distribution - US (nationwide) and to the countries of : Guam, United Arab Emirates, Australia, Belgium, Canada , China, Czech Republic, France, Germany, Luxembourg, Netherlands, Norway, Saudi Arabia, Sweden , Taiwan, and United Kingdom

Why it was recalled

The firm is providing customers with an updated Operations and Maintenance Manual for each of the BladderScan BVI 9600 and AortaScan AMI 9700 devices. The updated Operations and Maintenance Manuals clarify that these devices should not be used for the screening, detection, or diagnosis of abdominal aortic aneurysms (AAAs).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

BladderScan BVI 9600, Model Numbers: 0270-0451, 0270-0452, 0270-0754, and U270-0451. AortaScan AMI 9700, Model Numbers: 0270-0636, 0270-0639, and U270-0636.