Recall Z-1091-2016— Verathon, Inc.

Name: FDA recall Z-1091-2016
Creator: U.S. Food and Drug Administration
Published: 2015-11-30

Class II · Terminated

Class II FDA medical device recall by Verathon, Inc., initiated 2015-11-30, terminated 2016-10-12. It names one FDA 510(k) clearance: K082456. Product: 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.. Reason: 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)..

Recalling firm: Verathon, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-11-30
Terminated: 2016-10-12
Firm location: Bothell, WA, United States

510(k) clearances named in this recall

1 on FDA's record

K082456 — VERATHON INC. BLADDERSCAN ULTRASOUND SYSTEM, MODEL BVI 9600Verathon Incorporated·cleared 2008-12-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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).

Data sourced from openFDA. This site is unofficial and independent of the FDA.