Recall Z-2266-2012 ยท JAK System, X-Ray, Tomography, Computed
Toshiba American Medical Systems Inc
Toshiba CT systems, Asteion and Aquilion, that are equipped with a PC based computer, or to those older systems (SGI based) that received an improved table by an upgrade purchase. This device is designed to produce cross-sectional images of a human body by reconstruction of xray transmission data from the same axial plane taken at different angles. These images have been proven to be clinically
| Date | Aug 24, 2012 (initiated Feb 27, 2008) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process design |
| Action | 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 equipme |
| Quantity | 757 |
| Distribution | USA ( Nationwide Distribution ) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.