Recall Z-1675-2011 ยท IXR Table, Radiographic, Tilting
Toshiba American Medical Systems Inc
Toshiba DUA-450F Kalare Radiographic Tilting Table.
| Date | Mar 16, 2011 (initiated Jul 15, 2010) |
| Status | Terminated |
| Reason | Top table lateral movement on their DUA-450F Kalare Table cannot be performed, or the table top lateral movement is performed at an extremely low speed. As a result, positioning of the patient cannot be performed by tabletop movement. |
| Root cause | Software design |
| Action | Toshiba America Medical Systems (TAMS) issued Urgent Medical Device Correction notification dated July 8, 2010, to consignees via USPS return receipt mail. The letter contains a return reply form that is to be faxed to TAMS as proof of notification. |
| Quantity | 238 systems |
| Distribution | US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K922364 | DUA-900A IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYST Toshiba America Medical Systems, In.C, Sep 4, 1992 |