Company: Verathon, Inc.
Date of Enforcement Report 11/17/2010
Class ll:
PRODUCT
1) 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. Recall # Z-0003-2011;
2) AortaScan AMI 9700 The AortaScan AMI 9700 is an ultrasound device that projects ultrasound energy into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements. Recall # Z-0004-2011;
3) BladderScan BVM 9500 The BladderScan BVM 9500 is intended to project ultrasound energy through the lower abdomen to obtain an image of the bladder and measure urinary bladder volume and mass noninvasively. Recall # Z-0005-2011
REASON
The BladderScan BVI 9600 with AortaScan devices may experience the loss of a factory installed software configuration file which results in a loss of the aorta measurement function.
RECALLING FIRM/MANUFACTURER
Verathon, Inc., Bothell, WA, by letter dated August 12, 2010. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1) 351 units; 2) 73 units; 3) 260 units
DISTRIBUTION
Nationwide, Australia, Canada, China, Columbia, European Union, United Kingdom, Saudi Arabia, and Singapore
