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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 Recall
Toshiba America Medical Systems Inc Aplio Artida;
see related information
Date Posted May 10, 2011
Recall Status1 Terminated on May 25, 2011
Recall Number Z-2179-2011
Recall Event ID 55466
Premarket Notification
510(K) Number
K090158 
Product Classification System, Imaging, Pulsed Doppler, Ultrasonic - 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, California 92781-2068
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
DESIGN: 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 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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