Recall Z-0005-2009 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Toshiba American Medical Systems Inc
Toshiba Infinix fluoroscopy DFP-8000D Digital Radiography System with version 3.40 or higher software. Controller for Infinix interventional angiography systems.
| Date | Sep 28, 2009 (initiated Sep 29, 2008) |
| Status | Terminated |
| Reason | Audible signal is not available at all times when using the HLC fluoroscopy mode. Special means of activation are not designed in for selection of High Level Controls, as required by regulation. |
| Root cause | Software design |
| Action | Toshiba issued a letter entitled Important Electronic Product Radiation Warning, September 30, 2008, explaining the issue. The customers were requested to reply to the letter via fax-back form, and a Toshiba service representative would install the corrective action. |
| Quantity | 129 |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081624 | INFX-8000F (INFINIX CSI AND INFINIX DPI) Toshiba America Medical Systems, In.C, Jun 23, 2008 |