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U.S. Department of Health and Human Services

Class 2 Device Recall Aplio

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 Class 2 Device Recall Apliosee related information
Date Initiated by FirmFebruary 02, 2007
Date PostedJune 27, 2007
Recall Status1 Terminated 3 on April 18, 2012
Recall NumberZ-0986-2007
Recall Event ID 37965
510(K)NumberK022400 
Product Classification Ultrasound - Product Code IYN
ProductToshiba Aplio 50 Digital Ultrasound System, SSA-700A with version 6 software
Code Information Serial numbers:  B2622263,  B2622264,  B2622265, B2622267, B2622269,  B3522364, B3522365, B3522366, B3522369, B3522370, B3522372, B3522373, B3522402, B3522403, B3522404, B3522405, B3552542, B3552557, B3552558, B3552560, B3562595, B3562599, B3582672, B3582673, B3582674, C3592771, C3592772, C3592773, C3592774, D4553251, D4553252, D4553253, D4563327, D4563329, E4593563, E4593564, F4603654, F4603655, F4603656, F4613730, F4613731, F4613732, F5513813, G5523871 & G5523875  
Recalling Firm/
Manufacturer		 Toshiba American Med Sys Inc
2441 Michelle Dr
P.O. Box 2068
Tustin CA 92781-2068
For Additional Information ContactPaul Biggins
714-730-5000
Manufacturer Reason
for Recall		When using the LV measurement function and making numerous measurements the value displayed on the image screen may on occasion not update correctly. The values that are stored in MDA (measurement display area) are correct and no issue has been reported with these values.
FDA Determined
Cause 2		Other
ActionNotification letters were sent to customers on February 2, 2007. Customers were informed of the safety issue regarding the possibility of incorrect measurement values being displayed on the active image screen while performing multiple measurements and instructed to verify actual results against the values stored in the MDA (measurement display area). Customers were also informed that a Toshiba Customer Service Engineer will contact them to schedule a software upgrade when software becomes available. If customers have any questions they were instructed to contact their Toshiba Customer Service Engineer or call (800) 421-1968 and ask for the Regulatory Affairs Department. Customers were also instructed to distribute this information to all users of the product and also with the Bio-medical Department at their facility.
Quantity in Commerce45
DistributionNationwide
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = IYN
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