VERATHON Inc
AMI 9700 AortaScan and BVI 9600 BladderScan with AortaScan mode Safety Information Jan 2015
Safety Information
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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:
January 17, 2015
UNDERSTANDING AORTASCAN ACCURACY: The AortaScan can measure diameters ranging between 3 to 12.4 cm with a diameter accuracy of ± 15% ± 0.5 cm. This error-range data indicates a range of values obtained by the device relative to follow up and clinical significance, specifically with respect to risk vs. diameter.
* Source: Verathon AMI 9600 and 9700 Operations and Maintenance Manual
In summary, all prescribing physicians and users must be aware: -
The AortaScan is not a diagnostic device and is only intended as an initial screening tool. If clinically indicated, patients should be referred for a diagnostic standard (confirmatory) test, regardless of test results. The AortaScan is an ultrasound-based device subject to all limitations of this method. AortaScan accuracy specifications are ± 15% ± 0.5 cm, be aware of resulting tolerances when these ranges are applied.
If you have any questions regarding this information, please contact Verathon Customer Care at 800.331.2313; Option # 2. Additional information regarding the use of these products can be found on our website at http://verathon.com/products/aortascan/ami-9700 or http://verathon.com/products/bladderscan/bvi-9600. Sincerely,
Todd Berard 20001 North Creek Parkway Bothell, WA 98011 www.verathon.com
0014-0230-00-86