Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2179-2011

Toshiba America Medical Systems Inc. SSH-880CV Aplio Artida; Diagnostic Ultrasound System

Canon Medical Systems USA, Inc. / initiated 2010-04-20 / Terminated / root cause: design

Toshiba American Medical Systems Inc began a recall of Toshiba America Medical Systems Inc. SSH-880CV Aplio Artida; Diagnostic Ultrasound System on . The reason FDA records is "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". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-2179-2011
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Canon Medical Systems USA, Inc.
Product
Toshiba America Medical Systems Inc. SSH-880CV Aplio Artida; Diagnostic Ultrasound System
Product code
IYN System, Imaging, Pulsed Doppler, Ultrasonic
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.
Root cause tag
design
FDA root 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 [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.
Quantity in commerce
14
Distribution
USA, including Puerto Rico.
Product codes and lots
W1F09X2272, W1F0972220, W1F0992260, W1F0992262, W1H1012311, W1F0972219, W1F09Y2281, W1F0972218, W1F09X2270, W1F09X2271, W1F09Y2280, W1F09X2268, W1F09X2273, W1F09Y2282, W1F09Z2296, W1F09Z2297, W1F0992261