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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 Device Recall SSH880CV Aplio Artida; System, Diagnostic Ultrasound see related information
Date Initiated by Firm September 28, 2010
Date Posted March 03, 2011
Recall Status1 Terminated 3 on May 02, 2012
Recall Number Z-1498-2011
Recall Event ID 57303
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 CA 92781-2068
For Additional Information Contact
714-730-5000
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		 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 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) Database 510(K)s with Product Code = IYO and Original Applicant = TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
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