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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 Recall
Aplio XG model SSA790A
see related information
Date Posted August 10, 2011
Recall Status1 Terminated on April 20, 2012
Recall Number Z-2981-2011
Recall Event ID 55941
Premarket Notification
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, California 92781-2068
Consumer Instructions Contact the recalling firm for information
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
DESIGN: 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 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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