Recall Z-1177-2010 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Toshiba American Medical Systems Inc
Toshiba America Medical Systems Inc (TAMS) Digital Radiography System Radrex-i DRAD-3000E; Electrostatic x-ray imaging system
| Date | Mar 22, 2010 (initiated May 22, 2009) |
| Status | Terminated |
| Reason | Toshiba America Medical Systems Inc (TAMS) has initiated a field correction on the DRAD-3000E; Radrex-I, Electrostatic x-ray imaging system due to a software bug that results in a loss of image. |
| Root cause | Component design/selection |
| Action | An Urgent - Medical Device Correction letter was sent to customers. The letter described the issue, the corrective action, and the avoidance. Toshiba America Medical Systems informed customers that software was being prepared to address the issue and planned to send representatives to each customer affected by the field correction to provide a software upgrade to the DRAD-3000E; Radrex-I, Electrostatic x-ray imaging system. Customers were to complete the attached customer reply form. Questions were to be directed to Aaron Ybarra, X-ray Product Manager at 800-421-1968, ext. 2492. |
| Quantity | 20 |
| Distribution | Nationwide Distribution -- Including states of PA, VA, OH, TN, LA, IL, CA, MT, AZ, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K073165 | DRAD-3000E, RADREX-I Toshiba America Medical Systems, In.C, Nov 16, 2007 |