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Class 2 Device Recall Aplio Artida Ultrasound Diagnostic System SSH880CV |
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Date Initiated by Firm |
October 01, 2010 |
Date Posted |
July 29, 2011 |
Recall Status1 |
Terminated 3 on April 20, 2012 |
Recall Number |
Z-2897-2011 |
Recall Event ID |
57856 |
510(K)Number |
K090158
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Product Classification |
Ultrasound Diagnostic System - Product Code IYN
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Product |
Aplio Artida Ultrasound Diagnostic System SSH-880CV. Toshiba American Medical Systems, Inc.
A diagnostic ultrasound system. |
Code Information |
Last 4 of serial number: 2342, 2480, 2073, 2120, 2219, 2270, 2271, 2268, 2389, 2390, 2297, 2206, 2033, 2107, 2087, 2311, 2281, 2273, 2340, 2341, 2313, 2272, 2070, 2335, 2347, 2348, 2360, 2361, 2048, 2280, 2031, 2088, 2076, 2077, 2105, 2334, 2220, 2260, 2205, 2072, 2074, 2079, 2218, 2103, 2262, 2069, 2106, 2119, 2124, 2204, 2405, 2104, 2032, 2075, 2080, 2108, 2261, 2312, 2078, 2071, 2123, 2296, 2282, 2049, and 2056. |
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, Inc. is initiating a field correction on the Aplio Artida Ultrasound Diagnostic System because the panel operation for the Aplio Artida may become disabled (i.e., system may hang up) when processing to display patient information (heart rate, time, VCP counter, ect.).
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FDA Determined Cause 2 |
Software design |
Action |
Toshiba America Medical Systems, Inc. sent out an "Urgent Medical Device Correction" dated December 21, 2010 to all affected customers.
The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were notified that Toshiba will issue a field modification to correct the software, and if the problem occurs, they were instructed to shutdown the system holding down the power supply button for 5 seconds for 5 seconds and then restart the system. A form to send back to Toshiba is included.
For questions on this recall call (800) 421-1968 or contact your local Toshiba Representative at (800) 521-1968. |
Quantity in Commerce |
46 units |
Distribution |
Worldwide Distribution: (USA) Nationwide distribution including the states of MD, OH, PA, NY, MA, GA, AL, TX, IL, WI, IA, MN, KY, MT, OR, LA, and CA; and the country of Puerto Rico. |
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 = IYN and Original Applicant = TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
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