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U.S. Department of Health and Human Services

Class 2 Device Recall BladderScan BVI 9600 with Aorta Scan Mode

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  Class 2 Device Recall BladderScan BVI 9600 with Aorta Scan Mode see related information
Date Initiated by Firm August 23, 2010
Date Posted October 04, 2010
Recall Status1 Terminated 3 on September 08, 2011
Recall Number Z-0003-2011
Recall Event ID 56411
510(K)Number K082456  
Product Classification System, imaging, pulsed echo, ultrasonic - Product Code IYO
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.
Code Information 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.
Recalling Firm/
Manufacturer		 Verathon, Inc.
20001 N Creek Pkwy
Bothell WA 98011-8218
For Additional Information Contact Verathon Medical Customer Care
800-331-2313
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 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 in Commerce 351 units
Distribution Worldwide Distribution - USA and the countries of Australia, Canada, China, Colombia, European Union, United Kingdom, Saudi Arabia, and Singapore.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IYO and Original Applicant = VERATHON INCORPORATED
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