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U.S. Department of Health and Human Services

Class 2 Device Recall SSH880CV Aplio Artida; System, Diagnostic Ultrasound

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 Class 2 Recall
SSH880CV Aplio Artida; System, Diagnostic Ultrasound
see related information
Date Posted March 03, 2011
Recall Status1 Terminated on May 02, 2012
Recall Number Z-1498-2011
Recall Event ID 57303
Premarket Notification
510(K) Number
K090158 
Product Classification System, Imaging, Pulsed Echo, Ultrasonic - Product Code IYO
Product SSH-880CV Aplio Artida; System, Diagnostic Ultrasound
Code Information Serial Numbers (last 4): 2031, 2033, 2069, 2070, 2072, 2073, 2074, 2076, 2077, 2079, 2087, 2088, 2103, 2105, 2107, 2120, 2205, 2206, 2218, 2219, 2220, 2260, 2262, 2268, 2270, 2271, 2272, 2273, 2280, 2281, 2311, 2313, 2334, 2335, 2340, 2341, 2347, 2348, 2360, 2361, 2389, 2390, 2405, 2032, 2048, 2049, 2056, 2071, 2075, 2078, 2080, 2104, 2106, 2108, 2119, 2123, 2124, 2204, 2261, 2282, 2296, 2297, 2312, 2342, 2389, 2390, 2405
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 is initiating a field correction on the SSH-880CV Aplio Artida Diagnostic Ultrasound System due to software issues.
FDA Determined
Cause 2
DESIGN: Software Design
Action Toshiba America Medical Systems (TAMS) sent an URGENT MEDICAL DEVICE CORRECTION letter to consignees via USPS return receipt mail. The letter contained a return reply form that is to be faxed to TAMS at 877-349-3054 as proof of notification. Customers were instructed to share the information with all users and reviewing radiologists as well as clinical engineering or biomedical group at their facility. For questions regarding this recall call 800-421-1968 or 800-521-1968.
Quantity in Commerce 40 units
Distribution Nationwide Distribution to CA, GA, IA, IL KY, LA, MA, MN, MT, OH, OR, PA, TX, WI, and Puerto Rico.
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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