Recall Z-0533-06 ยท LLZ System, Image Processing, Radiological
Toshiba American Med Sys Inc
Toshiba America Medical Systems, Ultimax System MDX-8000A equipped with the EPS-Plus/ADR-1000A/E2D Digital Spot Film Device
| Date | Mar 29, 2006 (initiated Feb 23, 2006) |
| Status | Terminated |
| Reason | When the error condition occurs the x-ray exposures will terminate immediately. The digital system (EPS-Plus/ADR-1000A) will immediately stop acquiring images or will continue to acquire blank images. The remote console will lock-up upon release of the hand switch. The operator must reboot the system. This will result in the loss of the images acquired during the contrast portion of the study. |
| Root cause | Other |
| Action | Recall letter to be sent to to customers of affected devices beginning February 23, 2006. Corrected software to be issued by Toshiba America Medical Systems Inc, for all affected devices. |
| Quantity | 5 |
| Distribution | Nationwide to AZ, CA, FL, MT, & PA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K961307 | SMART SPOT Cmt Medical Technologies, Ltd., Jul 1, 1996 |