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U.S. Department of Health and Human Services

Class 3 Device Recall NEMIO XG

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 Class 3 Recall
NEMIO XG
see related information
Date Posted November 17, 2007
Recall Status1 Open
Recall Number Z-0254-2008
Recall Event ID 44811
Premarket Notification
510(K) Numbers
K061605 
Product Classification System, Imaging, Pulsed Doppler, Ultrasonic - Product Code IYN
Product NEMIO XG Ultrasound System, Model SSA-580A , Software versions: VI .5.0, Vl .5.000A, VI .5.000B, V2.0.0,Toshiba America Medical Systems, Inc., Tustin, CA.
Code Information SERIAL NUMBERS: A1A0642100 A1A0642102 A1B0662183 A1B0662184 A1B0662256 A1B0662257 A1B0662258 A1B0662327 A1B0662328 A1B0662330 A1B0662331 A1C06Z3155 A1C0713291 A1C0713292 A1C0713293 A1C0713294 A1C0713295 A1C0713296 A1C0713297 A1C0713298 A1C0713299 A1C0713300 A1C0713301 A1C0713379 A1C0723418 A1C0723419 A1C0723420 A1C0723540 A1C0723541 A1C0733580 A1C0733581 A1C0733610 A3A0652115 A3B0662284 A3B0662285 A3B0662286 A3B0662287 A3B0662288 A3B0662289 A3B0662290 A3B0662291 A3B0662292 A3B0662293 A3B0662371 A3B0662372 A3B0662373 A3B0662374 A3B0662375 A3B0662376 A3B0662377 A3B0662378 A3B0662379 A3B0662380 A3B0672415 A3B0672416 A3B0672417 A3B0672418 A3B0672419 A3C06Y3027 A3C06Z3065 A3C06Z3066 A3C06Z3067 A3C06Z3105 A3C06Z3106 A3C06Z3107 A3C06Z3108 A3C06Z3109 A3C06Z3110 A3C06Z3111 A3C0713345 A3C0713346 A3C0713347 A3C0713348 A3C0713349 A3C0713350 A3C0713351 A3C0723457 A3C0723458 A3C0723459 A3C0723460 A3C0723461 A3C0723462 A3C0723463 A3C0723464 A3C0723511 A3C0723512 A3C0723513 A3C0723514 A3C0723515 A3C0723516 A3C0723517 A3C0723518 A3C0723519 A3C0723520 A3C0723521 A3C0723522 A3C0723523 A3C0723524 A3C0723525 A3C0723526 A3C0723527 A3C0723528 A3C0723548 A3C0723549 A3C0723551 A3C0723552 A3C0723553 A3C0733572 A3C0733573 A3C0733574 A3C0733576 A3C0733577 A3C0733713 A3C0733714 A3C0733715 A3C0733716 A3C0733717 A3C0733718 A3C0733721 A3C0733722 A3C0733723 A3C0733724 A3C0733725 A3C0733727 A3C0733728 A3C0733729 A3C0733731 A3C0733732
Recalling Firm/
Manufacturer
Toshiba American Med Sys Inc
2441 Michelle Dr
P.O. Box 2068
Tustin, California 92781-2068
For Additional Information Contact Paul Biggins
714-730-5000
Manufacturer Reason
for Recall
Multiple problems including : (1) The surface temperature of the transducer tip can rise and exceed the limit set by the international standard. (2) Incorrect display of the TI indices on the display monitor. The displayed value is greater or smaller than the true TI value, and (3) Manuals contain incorrect values for MI/TI values.
FDA Determined
Cause 2
DESIGN: Device Design
Action Urgent Medical Device Notification letters were sent to customers on August 29, 2007. Customers were notified of the several issues related to the Nemio SSA-550A and Nemio SSA-580A recall and asked to share this information with all users of the device. Customers were informed that Toshiba is preparing software and corrected manuals for distribution to address these issues. If customers have any questions they were instructed to contact their Toshiba Customer Service Engineer or call (800) 421-1968 and ask for the Regulatory Affairs Department.
Quantity in Commerce 128 units
Distribution Nationwide
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 AMERICA MEDICAL SYSTEMS, INC.
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