Toshiba Artida Ultrasound User Manual

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  1. To access the digital manuals library, please follow this link. Customers from EU countries may request a printed copy of manuals by sending an email with the product model name and the manual number (at the top-right page of the digital manual) and their business contact details and address needed for the delivery to email.
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Class 2 Device Recall Aplio Artida Ultrasound Diagnostic System SSH880CV
Date Initiated by FirmOctober 01, 2010
Date PostedJuly 29, 2011
Recall Status1Terminated 3 on April 20, 2012
Z-2897-2011
Recall Event ID57856
K090158
Ultrasound Diagnostic System - Product CodeIYN
ProductAplio Artida Ultrasound Diagnostic System SSH-880CV.
Toshiba American Medical Systems, Inc.
A diagnostic ultrasound system.
Code InformationLast 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
For Additional Information Contact
714-730-5000
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.).
Software design
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.
46 units
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.
TPLC Device Report
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.
510(K) Database510(K)s with Product Code = IYN and Original Applicant = TOSHIBA AMERICA MEDICAL SYSTEMS, INC.