Recall Z-1714-2014 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Toshiba American Medical Systems Inc
Toshiba Infinix X-Ray Interventional System INFX-8000V/UU. An X-Ray system that is capable of radiographic and fluoroscopic studies used in an interventional setting.
| Date | Jun 4, 2014 (initiated May 12, 2014) |
| Status | Terminated |
| Reason | Although the Flat Panel Detector (FPD) touch sensor is activated during use, the error message is displayed and the audible signal continues sounding during the table movement of longitudinal tilt, the movement of longitudinal tilt does not stop. |
| Root cause | Other |
| Action | Toshiba America Medical Systems, Inc. initiated this recall by sending recall notifications via USPS return receipt mail. The recall notification letter, dated May 12, 2014, titled "URGENT: MEDICAL DEVICE CORRECTION", informed customers of the following: device information, serial number, SID, reason for reason, purpose of the notification, corrective action, request to customers, contact information, and customer reply form. Customers with questions regarding this letter were instructed to call (800) 421-1968 or contact their local Toshiba Representative at (800) 521-1968. For questions regar |
| Quantity | 2 |
| Distribution | Nationwide Distribution including CA and IN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120073 | INFX-8000V WITH Toshibamedical Systems Corporation, Jan 26, 2012 |