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U.S. Department of Health and Human Services

Class 2 Device Recall Aplio 80

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 Class 2 Recall
Aplio 80
see related information
Date Posted March 19, 2010
Recall Status1 Terminated on April 18, 2012
Recall Number Z-1172-2010
Recall Event ID 52832
Premarket Notification
510(K) Number
K041499 
Product Classification System, Imaging, Pulsed Doppler, Ultrasonic - Product Code IYN
Product Aplio 80; SSA-770A; software version 5.5r002
Code Information F4603656, F4603654, F4613731, F5513813, F4613730, F4613732, G5523875, G5523871, A2542234, F4603309, F450331, F4603314, F4603317, D3622941, F4603315, F4623389, F4613351, F4613356, F4613352, F4613353, F5513467, F4613339, F5513458, F5513433, F5513448, F5513452, F5513431, F5513439, F4613344, F5513455, F4623391, F5513464, F4623378, F4313338, F4613341, F4613343, F5513437, F5513451, F5513469, 5F513450, F4623379, F4623388, F4623375, F4623383, F5513446, F4623392, F5513449, F4613337, F4623381, F4623377, F5513460, F4623380, F4613342, F5513430, F5513463, F5513445, F4623390, F5513461, F5513462, F5513432, 80G0543639, 80G0543628, 80G0593786, G5523558, 80G0543644, 80G0543643, G5523519, G5523536, G5523544, 80G0523567, 80G0593789, 80G0593774, G5523513, G5523514, G5523564, G5523563, 80G0543637, G5523562, 80G0583731, 80G0593794, 80G0583728, 80G0593790, 80G0593791, 80G0593773, 80G0543640, 80G0593793, 80G0523565, 80G0543636, 80G0543645, G5523538, 80G0543627, 80G0583730, 80G0593792, G5523559, 80G0543625, G5523539, G5523541, G5523537, 80G0583727, 80G0593785, 80G0593802, and 80G0593803.
Recalling Firm/
Manufacturer
Toshiba American Medical Systems Inc
2441 Michelle Dr
P.O. Box 2068
Tustin, California 92781-2068
Manufacturer Reason
for Recall
Toshiba America Medical System Inc initiated a field corrective action on Aplio 50; SSA-700A; software version 5.5r002 and later, Aplio 80; SSA-700A; software version 5.5r002 and later, and Xario; SSA-660A; software version 1.0 and later, because the product does not meet the Safety Standard requirements.
FDA Determined
Cause 2
DESIGN: Component Design/Selection
Action Toshiba America Medical Systems (TAMS) has issued a Field Modification Instruction notification to all of its customers about the affected devices. The correct software will be administered through TAMS' representatives. Reimbursement for the modification will be given upon receipt of the reimbursement claim invoice.
Quantity in Commerce 94 units
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = IYN and Original Applicant = TOSHIBA MEDICAL SYSTEMS CORPORATION
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