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U.S. Department of Health and Human Services

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

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 Class 2 Device Recall Toshiba America Medical Systems Inc Aplio Artida;see related information
Date Initiated by FirmApril 20, 2010
Date PostedMay 10, 2011
Recall Status1 Terminated 3 on May 25, 2011
Recall NumberZ-2179-2011
Recall Event ID 55466
510(K)NumberK090158 
Product Classification Diagnostic Ultrasound System - Product Code IYN
ProductToshiba 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 2		Device Design
ActionThe 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 Commerce14
DistributionUSA, including Puerto Rico.
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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