Recall Z-0994-2013 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Toshiba American Medical Systems Inc
Toshiba Infinix-i X-Ray System. A radiographic and fluoroscopic x-ray system for use in diagnostic and angiographic procedures.
| Date | Mar 25, 2013 (initiated Nov 8, 2012) |
| Status | Terminated |
| Reason | Lost and incorrect images. When using the "F-Rec" fluoroscopy image acquisition recording option in the "manual mode" an infrequent software error may cause images from another study to be displayed on the monitor. The acquired images may be lost requiring additional image acquisitions to be performed. |
| Root cause | Software design |
| Action | In November, 2012, Toshiba America Medical Systems, Inc. sent an Urgent: Medical Device Correction letter to customers. The letter contains a return reply form that is to be faxed to TAMS for retention. |
| Quantity | 95 units |
| Distribution | USA nationwide. No international. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052884 | MODEL DFP-8000D/FPD DIGITAL RADIOGRAPHY SYSTEM WITH FLAT PANEL DETECTOR Toshiba America Medical Systems, In.C, Oct 26, 2005 |
| K081624 | INFX-8000F (INFINIX CSI AND INFINIX DPI) Toshiba America Medical Systems, In.C, Jun 23, 2008 |
| K113052 | INFINIX-CCI Toshiba America Medical Systems, In.C, Nov 22, 2011 |
| K120073 | INFX-8000V WITH Toshibamedical Systems Corporation, Jan 26, 2012 |