BVI 9600 Bladder Volume Instrument, Aorta Scan Mode The BladderScan BVI 9600 with AortaScan Mode is a user-selectable, dual-function ultrasound device that projects ultrasound energy either into the lower abdomen to obtain an image of the bladder for measuring bladder volume, or into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements.
FDA Recall Z-0003-2011 · Posted 2010-10-04
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Reason for Recall
Firm Action
Root Cause
Software design
Distribution Pattern
Worldwide Distribution - USA and the countries of Australia, Canada, China, Colombia, European Union, United Kingdom, Saudi Arabia, and Singapore.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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