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U.S. Department of Health and Human Services

Class 3 Device Recall NEMIO XG

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 Class 3 Device Recall NEMIO XG see related information
Date Posted November 17, 2007
Recall Status1 Terminated on April 05, 2012
Recall Number Z-0254-2008
Recall Event ID 44811
510(K)Number K061605 
Product Classification Ultrasound System - 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 CA 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
Software 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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