Toshiba America Medical Systems Inc. SSH-880CV Aplio Artida; Diagnostic Ultrasound System
FDA Recall Z-2179-2011 · Posted 2011-05-10
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Recalling FirmToshiba American Medical Systems Inc
Recall StatusTerminated
Product CodeIYN
Date Initiated2010-04-20
Date Terminated2011-05-25
Product Quantity14
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.
Firm 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 [email protected]. If customers had any questions they can call Paul Biggins at (800) 421-1968 or contact their local Toshiba Representative at (800) 521-1968.
Root Cause
Device Design
Distribution Pattern
USA, including Puerto Rico.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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