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U.S. Department of Health and Human Services

Class 3 Device Recall NEMIO

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 Class 3 Device Recall NEMIO see related information
Date Posted November 17, 2007
Recall Status1 Terminated on April 05, 2012
Recall Number Z-0253-2008
Recall Event ID 44811
510(K)Number K043078 
Product Classification Ultrasound System - 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 602163
P6612218
P6612221
P7533088
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P7533112
P7533178
B1542260
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L4
Recalling Firm/
Manufacturer
Toshiba American Med Sys Inc
2441 Michelle Dr
P.O. Box 2068
Tustin CA 92781-2068
714-730-5000
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 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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