Retiro De Equipo (Recall) de Toshiba America Medical Systems Inc Aplio Artida;

Recall

55466

Class 2

Z-2179-2011

2010-04-20

2011-05-10

Terminated

United States

2011-05-25

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90928

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.

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.