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U.S. Department of Health and Human Services

Class 3 Device Recall NEMIO

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 Class 3 Recall
NEMIO
see related information
Date Posted November 17, 2007
Recall Status1 Open
Recall Number Z-0253-2008
Recall Event ID 44811
Premarket Notification
510(K) Numbers
K061605 
Product Classification System, Imaging, Pulsed Echo, Ultrasonic - Product Code IYO
Product NEMIO Ultrasound System, Model SSA-550A , Software versions: V3.1.000B, V3.5.0, V3.5.000A, V3.5.000B, V3.6.0, V3.6.000A, V4.0.0, V4.0.000A, V4.l.0, V4.l.000A, V4.2.0, V4.3.0, V4.5.0, V4.5.000A, Toshiba America Medical Systems, Inc., Tustin, CA.
Code Information SERIAL NUMBERS: C1592849 E2524072 E2524073 E2524074 E2524075 E2524076 E2524077 E2524078 E2524079 E2524080 E2524081 E2524082 E2524083 E2524084 E2524085 E2524086 E2534236 E2534237 E2534238 E2534239 E2534240 E2534241 F2534286 F2534287 F2534288 F2534289 F2534290 F2534291 F2534292 F2544351 F2544352 F2544353 F2544354 F2544355 F2544356 F2544357 F2544358 F2544427 F2544428 F2544429 F2544430 F2544431 F2544432 F2544433 F2544451 F2544452 F2544453 F2544505 F2544506 F2544507 F2544508 F2544509 F2544510 F2544511 F2544512 F2544513 F2544514 F2544515 F2544516 F2544517 F2544518 F2544519 F2544520 F2544521 F2544522 F2544523 F2544524 F2544525 F2544526 F2564733 F2564734 F2564735 F2564736 F2564737 F2564738 F2564739 F2564740 F2564741 F2564742 F2564743 F2564744 H2626535 H2626536 H2626537 H2626538 H2626539 H2626540 H2626541 H3516932 H3516933 H3516934 H3516935 H3516936 H3516937 I3522331 I3522332 I3522333 I3522334 I3522335 I3522336 I3522337 I3522338 I3522339 I3522340 I3522341 I3522342 I3522343 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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 1,278 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 = IYO and Original Applicant = TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
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