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U.S. Department of Health and Human Services

Class 2 Device Recall SSH880CV Aplio Artida

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 Class 2 Recall
SSH880CV Aplio Artida
see related information
Date Posted May 19, 2011
Recall Status1 Terminated on April 20, 2012
Recall Number Z-2203-2011
Recall Event ID 55543
Premarket Notification
510(K) Number
K090158 
Product Classification System, Imaging, Pulsed Doppler, Ultrasonic - Product Code IYN
Product Software for SSH-880CV Aplio Artida; System Diagnostic Ultrasound
Code Information W1A0822031-33, W1A0822048-49, W1A0832056, W1A0842069-70, W1B0852071-80, W1B0862087-8, W1C0872103-08, W1C0882119-24, W1F0972204-06, W1F0972218-20, W1F0992260-62, W1F0992268, and W1F0992270-73.
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 (TAMS) has become aware that the FLEX M software has reversed left and right annotation and post FLEX M measurement error, which may result in incorrect values.
FDA Determined
Cause 2
DESIGN: Software Design
Action The recall communication was initiated on 1/6/10 with Toshiba forwarding an Urgent: Medical Device Correction letter with attached Customer Notification Reply Form (via US Postal Service for US Customers) to all customers who purchased the FLEX-M mode on Aplio Artida Diagnostic Ultrasound System. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to avoid performing M image measurement using images saved in FLEX-M mode until the corrective action is completed. If customers need to perform measurement for images saved in FLEX-M mode, they were instructed to use manual calibration. Customers were instructed to note that even though the corrective action is taken, the existing saved images (saved images before the corrective action is taken) are not modified. Therefore, when referring to the measured values on the images which are saved in FLEX-M mode before the corrective action is taken, customers were instructed to carefully handle the measurements results because they may be incorrect. Customers were instructed to complete the attached form and fax it to the toll free number at the top of the form. The form can also be sent via e-mail to raffairs@tams.com. If customers have any questions regarding the medical device correction letter, they can contact the Director of Regulatory Affairs at (800) 421-1968 or their local Toshiba representative.
Quantity in Commerce 28
Distribution Nationwide Distribution -- Including states of IA, MT, PA, CA, OR, GA, LA, OH, TX, MA, OH, WI, and Puerto Rico.
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 = IYN and Original Applicant = TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
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