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U.S. Department of Health and Human Services

Class 2 Device Recall SSH880CV Aplio Artida System

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 Class 2 Recall
SSH880CV Aplio Artida System
see related information
Date Posted July 06, 2010
Recall Status1 Terminated on March 21, 2012
Recall Number Z-1955-2010
Recall Event ID 55774
Premarket Notification
510(K) Number
K090158 
Product Classification System, Imaging, Pulsed Echo, Ultrasonic - Product Code IYO
Product SSH-880CV Aplio Artida System
Code Information 2031, 2032, 2033, 2048, 2049, 2056, 2069, 2070, 2071, 2072, 2073, 2074, 2075, 2076, 2077, 2078, 2079, 2080, 2087, 2088, 2103, 2104, 2105, 2106, 2707, 2108, 2119, 2120, 2123, 2124, 2204, 2205, 2206
Recalling Firm/
Manufacturer
Toshiba American Medical Systems Inc
2441 Michelle Dr
P.O. Box 2068
Tustin, California 92781-2068
Manufacturer Reason
for Recall
Toshiba America Medical Systems (TAMS) is initiating a field correction on the SSH-880CV Aplio Artida System due to a problem related to a wrong measurement value display in using with DICOM viewer. When an image is transferred from this system in DICOM transfer and a measurement is performed on a Doppler image in the DICOM viewer, measured values such as VTI (Velocity Time Integral) and PI/RI
FDA Determined
Cause 2
DESIGN: Software Design
Action The software will be replaced. To accomplish this, Toshiba America Medical Systems (TAMS) will notify consignees via USPS return receipt mail. The letter contains a return reply form that is to be faxed to TAMS for retention. For questions or concerns, please contact your Toshiba representative or the firm at (714) 730-5000.
Quantity in Commerce 22
Distribution Nationwide ((CA, GA, IA, LA, MA, MD, MN, MT, PA, PR, OH, OR, TN).
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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