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