Verathon, Inc.: 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 number

Z-0003-2011

Recalling firm

Verathon, Inc.

Product

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.

Status

Terminated

Initiated

2010-08-23

Posted

2010-10-04

Terminated

2011-09-08

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.

Root cause

Software design

Action

Verathon sent an URGENT Medical Device Recall Notification letter dated August 12, 2010 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Verathon provided an addendum to the User Manual with instructions on how to reset the instrument. Customers were advised to: " Add the enclosed addendum to their current Users Manual. " Update the application software of the device to v2.7.0 or higher. If the customers had questions or needed support for the software update process, they were to contact Verathon Medical Customer Care at (425) 867-1348 or (800) 331-2313 or cservice@verathon.com.

Quantity

351 units

Distribution

Worldwide Distribution - USA and the countries of Australia, Canada, China, Colombia, European Union, United Kingdom, Saudi Arabia, and Singapore.

Lot, serial or model codes

Serial numbers:   B6001061, B6001062, B6001063, B6001064, B6001065, B6001066, B6001067, B6001068, B6001069, B6001070, B6001071, B6001072, B6001073, B6001074, B6001075, B6001076, B6001077, B6001078, B6001079, B6001080, B6001081, B6001082, B6001083, B6001084, B6001085, B6001086, B6001088, B6001090, B6001092, B6001093, B6001097, B6001098, B6001103, B6001104, B6001107, B6001108, B6001109, B6001110, B6001111, B6001112, B6001113, B6001134, B6001164, B6001166, B6001167, B6001168, B6001169, B6001170, B6001172, B6001173, B6001174, B6001175, B6001176, B6001177, B6001178, B6001179, B6001181, B6001184, B6001185, B6001186, B6001187, B6001188, B6001189, B6001190, B6001191, B6001192, B6001198, B6001199, B6001200, B6001201, B6001202, B6001203, B6001204, B6001205, B6001206, B6001207, B6001208, B6001209, B6001211, B6001212, B6001213, B6001215, B6001216, B6001217, B6001218, B6001219, B6001220, B6001221, B6001223, B6001224, B6001225, B6001232, B6001233, B6001234, B6001239, B6001240, B6001242, B6001243, B6001244, B6001245, B6001251, B6001253, B6001254, B6001255, B6001256, B6001257, B6001258, B6001259, B6001260, B6001261, B6001263, B6001265, B6001267, B6001269, B6001270, B6001271, B6001272, B6001273, B6001277, B6001278, B6001279, B6001280, B6001281, B6001282, B6001283, B6001284, B6001285, B6001286, B6001287, B6001288, B6001289, B6001290, B6001291, B6001292, B6001293, B6001294, B6001295, B6001296, B6001297, B6001298, B6001299, B6001300, B6001301, B6001302, B6001305, B6001306, B6001307, B6001308, B6001309, B6001310, B6001311, B6001312, B6001313, B6001314, B6001315, B6001316, B6001317, B6001318, B6001319, B6001320, B6001321, B6001322, B6001323, B6001324, B6001325, B6001326, B6001327, B6001328, B6001329, B6001330, B6001331, B6001332, B6001333, B6001336, B6001337, B6001338, B6001339, B6001340, B6001341, B6001342, B6001343, B6001345, B6001346, B6001347, B6001348, B6001349, B6001350, B6001351, B6001353, B6001354, B6001355, B6001356, B6001357, B6001358, B6001359, B6001360, B6001361, B6001362, B6001363, B6001364, B6001365, B6001366, B6001367, B6001368, B6001369, B6001370, B6001371, B6001372, B6001373, B6001374, B6001375, B6001377, B6001378, B6001379, B6001380, B6001381, B6001382, B6001383, B6001384, B6001385, B6001386, B6001387, B6001388, B6001389, B6001390, B6001391, B6001392, B6001393, B6001394, B6001395, B6001396, B6001397, B6001398, B6001399, B6001401, B6001402, B6001403, B6001404, B6001405, B6001406, B6001407, B6001408, B6001409, B6001410, B6001411, B6001413, B6001415, B6001416, B6001418, B6001419, B6001421, B6001422, B6001423, B6001424, B6001425, B6001426, B6001427, B6001432, B6001433, B6001435, B6001436, B6001437, B6001438, B6001439, B6001440, B6001441, B6001442, B6001443, B6001444, B6001445, B6001446, B6001447, B6001448, B6001449, B6001450, B6001451, B6001452, B6001453, B6001454, B6001455, B6001456, B6001457, B6001463, B6001464, B6001465, B6001466, B6001467, B6001468, B6001469, B6001470, B6001471, B6001472, B6001473, B6001474, B6001475, B6001476, B6001477, B6001478, B6001479, B6001481, B6001482, B6001483, B6001485, B6001486, B6001487, B6001488, B6001489, B6001490, B6001491, B6001492, B6001493, B6001495, B6001496, B6001497, B6001498, B6001499, B6001500, B6001501, B6001502, B6001503, B6001505, B6001506, B6001507, B6001508, B6001509, B6001510, B6001511, B6001512, B6001513, B6001514, B6001516, B6001517, B6001518, B6001519, B6001520, B6001522, B6001523, B6001524, B6001525, B6001529, B6001530, B6001532, B6001533, B6001534, B6001539, B6001540, B6001542, B6001545, B6001547, B6001548, and B6001549.

510(k) numbers

["K082456"]

PMA numbers

not on file

Product code

IYO

Firm FEI

3022472

Firm city

Bothell

Firm state

WA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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