VERATHON Inc

AMI 9700 AortaScan and BVI 9600 BladderScan with AortaScan mode Safety Information Jan 2015

Safety Information

2 Pages

January 17, 2015  ** Attention - Important Product Information ** Subject: Important Safety Information for all Verathon AMI 9700 AortaScan and BVI 9600 BladderScan with AortaScan mode Users  Dear Valued Customer, Verathon has received several customer complaints concerning the accuracy of the AortaScan feature. Specifically, some of the complaints stated that patients with known Abdominal Aortic Aneurysms (AAA), as determined by other diagnostic methods, were not detected by the Verathon AortaScan device. As a result of intensive investigations, Verathon has not detected any product malfunction that may have lead to these complaints. Verathon will continue to monitor customer feedback, however we feel it is important that all prescribing physicians and users be aware of the following information: INTENDED USE:  The AortaScan AMI 9700 or BVI 9600 in Aorta scan mode is an ultrasound device that projects ultrasound energy into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements.  NEW PRODUCT WARNINGS:
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