Toshiba CT systems, Asteion and Aquilion, that are equipped with a PC based computer, or to those older systems (SGI bas

FDA device recall Z-2266-2012 · posted 2012-08-24 · Terminated

Recall details

Recalling firm

Toshiba American Medical Systems Inc

Reason for recall

The systems all have a similar table control board. It has been found that this board may cause the table position to be incorrect if the table cradle is moved manually. This is referred to as "Free" mode in the operation manuals. If this error does occur it is possible that the patient could be scanned at an incorrect position.

Action taken

Toshiba sent a "URGENT: MEDICAL DEVICE CORRECTION" letter to all affected customers. The letter identified the product, the problem, and the action needed to be taken by the customer. Customers were instructed to please avoid moving the table in the "Free" or manual mode as much as possible. If it is necessary to move the table in this manner please verify the table position prior to initiating the scan sequence. If it is noted that the position is not correct, exit the eXam plan and start a new one beginning with the scanoscopy. Please share this information with all users of the equipment and your clinical or biomedical engineering departments. Please find the attached customer reply form. The purpose of this form is for FDA tracking. Please take a moment to complete the form and fax it to the toll free number on the form.". The contact information for this recall is:"(800) 421-1968 or contact your local Toshiba Representative at (800) 521-1968.".

Root cause

Process design

Status

Terminated

Product code

JAK

Quantity affected

757

Distribution

USA ( Nationwide Distribution )

Date initiated

2008-02-27

Date posted

2012-08-24

Date terminated

2012-09-04

Location

Tustin, CA