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Class 2 Device Recall SSH880CV Aplio Artida System |
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Date Initiated by Firm |
September 16, 2009 |
Date Posted |
July 06, 2010 |
Recall Status1 |
Terminated 3 on March 21, 2012 |
Recall Number |
Z-1955-2010 |
Recall Event ID |
55774 |
510(K)Number |
K090158
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Product Classification |
system, imaging, pulsed doppler, ultrasonic - Product Code IYO
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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 CA 92781-2068
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For Additional Information Contact |
714-730-5000
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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
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FDA Determined Cause 2 |
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
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = IYO and Original Applicant = TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
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