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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 August 04, 2016
Create Date August 16, 2016
Recall Status1 Terminated 3 on November 17, 2017
Recall Number Z-2542-2016
Recall Event ID 74876
510(K)Number K143046  K143027  
Product Classification System, imaging, pulsed doppler, ultrasonic - Product Code IYN
Product Xario 100 Diagnostic Ultrasound System, TUS-X100; Xario 200 Diagnostic Ultrasound System, TUS-X200.
Code Information 99B1422854 99B1422858 99B1422859 99B1422860 99B1422861 99B1422862 99B1422863 99B1433093 99B1433097 99B1433098 99B1433100 99B1443176 99B1443177 99B1443178 99B1443179 99B1443180 99B1453269 99B1453270 99B1453271 99B1453272 99B1453273 99B1453274 99B1453277 99B1453278 99B1453293 99B1453294 99B1453295 99B1453296 99B1453297 99B1453300 99B1453301 99B1453302 99B1453303 99B1453304 99B1463369 99B1463370 99B1463371 99B1463372 99B1463373 99B1463376 99B1463377 99B1463378 99B1463379 99B1463380 99B1493642 99B1493643 99B1493644 99B1493645 99B1493646 99B1493647 99B1493648 99B1493649 99B1493650 99B1493651 99B1493716 99B1493717 99B1493719 99B1493720 99C1554630 99C1554631 99C1554632 99C1554633 99C1554634 99C1554635 99C1564695 99C1564696 99C1564697 99C1564698 99C1564699 99C1564700 99C1564701 99C1564704 99C1574785 99C1574786 99C1574787 99C1574788 99C1574789 99C1574790 99C1574791 99C1574792 99C1574793 99C1574794 99C1574795 99C1574796 99C1574797 99C1574798 99C1574799 99B1422855 99B1422856 99B1422857 99B1433091 99B1433092 99B1433094 99B1433095 99B1433096 99B1433099 99B1453275 99B1453276 99B1493718 99C1524295 99C1564702 99C1564703 
Recalling Firm/
Manufacturer		 Toshiba American Medical Systems Inc
PO Box 2068
2441 Michelle Dr
Tustin CA 92780-7047
For Additional Information Contact
714-730-5000
Manufacturer Reason
for Recall		 Toshiba American Medical Systems (TAMS) is recalling the Xario Diagnostics Ultrasound System because it may become hot because of a software error.
FDA Determined
Cause 2		 Software design
Action An Urgent Medical Device Correction letter was sent to all customers to bring to attention a potential problem of transducer heating with your Xario Ultrasound System. The letter informs the customers that the surface of the acoustic lens of a transducer may become hot because of a software error. The error occurs when a transducer is disconnected, reconnected, or another transducer is selected. The letter informs the customers of error message and the corrective action. Customers are instructed to complete the attached form and fax it to (877) 349-3054 or TAMS-RegulatoryAffairs@toshiba.com. Customer with any questions are instructed to call (714) 730-5000 or their Toshiba service representative at (800) 521-1968.
Quantity in Commerce 93 units
Distribution US 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 MEDICAL SYSTEMS CORPORATION
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