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U.S. Department of Health and Human Services

Class 2 Device Recall Aplio XG model SSA790A

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  Class 2 Device Recall Aplio XG model SSA790A see related information
Date Initiated by Firm June 02, 2010
Date Posted August 10, 2011
Recall Status1 Terminated 3 on April 20, 2012
Recall Number Z-2981-2011
Recall Event ID 55941
510(K)Number K091295  
Product Classification System, imaging, pulsed echo, ultrasonic - Product Code IYO
Product Aplio XG model SSA-790A

Aplio XG (SSA-790A) is a premium-class diagnostic ultrasound system incorporating state-of-the-art technologies. It is provided with the highest level of image quality and operability (reflecting the XG (next Generation) in its name), and can be used with ease for research as well as for routine clinical studies.
Code Information 4899 5131, 5132, 5133, 5134, 5224, 5139, 5260, 5261, 5369, 5256, 5367, 4883, 4884, 5370, 5374, 5375, 5264, 5257, 5135, 5223, 5379, 5262, 6283, 4886, 5258, 5382, 5383, 5384, 5385, 5216, 4887, 4897, 4898, 5027, 5380, 4982, 5026, 5137, 5138, 5219, 5220, 4979, 5465, 4900, 5466, 4978, 5377, 5136, 5376, 5072, 5071, 5221, 5215, 4981, 5371, 5372, 5373, 5029, 5030, 5068, 5069, 5070, 5222, 4980, 4885, 5259, 5028, 4896, 5368, 5217, 5218, 5140, 5265, 5364, 5365, 5366, 5381, 5467, 5468, 5469, 5470, 5471, 5472, 5473, 5474
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 Inc (TAMS) is initiating a field correction on the the Aplio XG model SSA-790A because it did not meet the requirement of clause 15b, IEC60601-1 which requires that the residual voltage shall not exceed 60V after 1 second from taking off the AC plug.
FDA Determined
Cause 2		 Device Design
Action Toshiba America Medical Systems (TAMS) sent an "URGENT:MEDICAL DEVICE CORRECTION' letter dated June 2, 2010 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. Customers were instructed to be careful not to touch the contacts or prongs on the AC plug within two seconds after unplugging the system from a wall socket. This precaution is to be adhered to until a Toshiba Service Representative replaces the power supply. Customers are to complete and return a Customer Reply Form and fax to 877-349-3054. Customers with questions regarding the notification should contact the Director of Regulatory Affairs at (800) 421-1968 or call their local Toshiba Representative at (800) 521-1968.
Quantity in Commerce 78
Distribution Nationwide Distribution
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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