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U.S. Department of Health and Human Services

Class 2 Device Recall Xario

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  Class 2 Device Recall Xario see related information
Date Initiated by Firm November 12, 2007
Date Posted March 19, 2010
Recall Status1 Terminated 3 on April 18, 2012
Recall Number Z-1173-2010
Recall Event ID 52832
510(K)Number K050380  
Product Classification Ultrasonic Pulsed Doppler Imaging System - Product Code IYN
Product Xario; SSA-660A; software version 1.0 and later
Code Information 99B0552623, 99B0552625, 99B0552649, 99B0552629, 99B0562684, 99B0552648, 99B0593233, 99B0552592, 99B0583053, 99B0572841, 99B0562671, 99B0562673, 99B0572834, 99B0572894, 99B0552590, 99B0572895, 99B0562672, 99B0572839, 599B052651, 99B0593228, 99B0562685, 99B0593227, 99B0552612, 99B0572840, 99B0552650, 99B0562674, 99B0552652, 99B0552653, 99B0552654, 99B0552646, 99B0552627, 99B0552574, 99B0572898, 99B0472046, 99B0583050, 99B0562689, 99B0572821, 99B0572897, 99B0572835, 99B0572837, 99B0572838, 99B0572836, 99B0572822, 99B0552615, 99B0552616, 99B0552621, 99B0552597, 99B0593210, 99B0552598, 99B0552647, 99B0552655, 99B0552593, 99B0552591, 99B0593236, 99B0552577, 99B0552579, 99B0552630, 99B0583049, 99B0552569, 99B0552567, 99B0593213, 99B0552617, 99B0552624, 99B0552599, 99B0583048, 99B0583052, 99B0593211, 99B0552595, 99B0552619, 99B0552620, 99B0593229, 99B0593230, 99B0583047, 99B0583045, 99B0552594, 99B0552578, 99B0552568, 99B0552575, 99B0552576, 99B0552631, 99B0552570, 99B0552613, 99B0552626, 99B0562686, 99B0583051, 99B0593235, 99B0552618, 99B0562687, 99B0593234, 99B0593232, 99B0552614, 99B0552628, 99B0572869, 99B0552584, 99B0593231, 99B0552622, 99B0562675, 99B0593209, and  99B0593212.      
Recalling Firm/
Manufacturer		 Toshiba American Medical Systems Inc
2441 Michelle Dr
P.O. Box 2068
Tustin CA 92781-2068
For Additional Information Contact
714-730-5000
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		 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 98 units
Distribution Nationwide Distribution
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 = IYN and Original Applicant = TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
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