Class 2 Device Recall SSH880CV Aplio Artida

• Date Initiated by Firm: January 06, 2010
• Date Posted: May 19, 2011
• Recall Status: Terminated on April 20, 2012
• Recall Number: Z-2203-2011
• Recall Event ID: 55543
• 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 CA 92781-2068
• For Additional Information Contact: 714-730-5000
• 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: 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 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 = IYN and Original Applicant = TOSHIBA AMERICA MEDICAL SYSTEMS, INC.