Class 2 Device Recall Toshiba America Medical Systems Inc Aplio Artida;

• Date Initiated by Firm: April 20, 2010
• Date Posted: May 10, 2011
• Recall Status: Terminated on May 25, 2011
• Recall Number: Z-2179-2011
• Recall Event ID: 55466
• 510(K)Number: K090158
• Product Classification: Diagnostic Ultrasound System - Product Code IYN
• Product: Toshiba America Medical Systems Inc. SSH-880CV Aplio Artida; Diagnostic Ultrasound System
• Code Information: W1F09X2272, W1F0972220, W1F0992260, W1F0992262, W1H1012311, W1F0972219, W1F09Y2281, W1F0972218, W1F09X2270, W1F09X2271, W1F09Y2280, W1F09X2268, W1F09X2273, W1F09Y2282, W1F09Z2296, W1F09Z2297, W1F0992261
• 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: There is a possibility of the system shutting down owing to the power supply unit causing the protection function to activate thus turning off the system prematurely.
• FDA Determined Cause: Device Design
• Action: The recall was initiated on 4/20/10 with Toshiba America Medical Systems (TAMS) forwarding a Medical Device Correction with a Customer Reply Form (via US Postal Service for US Customers) to all customers who purchased the SSH-880CV 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 this problem until corrective action is taken, in case this problem occurs; please contact their Toshiba Representative. If emergency use is necessary, use the following procedure which allows the system to be used temporarily: 1. Turn OFF the breaker at the back of the system and confirm that the error code near the breaker disappears. 2. Turn ON the breaker again to supply power to the system. Customers were instructed to complete and return the attached form and fax it to the toll free number at the top of the form. This form can also be sent via email to raffairs@tams.com. If customers had any questions they can call Paul Biggins at (800) 421-1968 or contact their local Toshiba Representative at (800) 521-1968.
• Quantity in Commerce: 14
• Distribution: USA, including 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.