Toshiba America Medical Systems, Ultimax System MDX-8000A equipped with the EPS-Plus/ADR-1000A/E2D Digital Spot Film Dev
FDA device recall Z-0533-06 · posted 2006-03-29 · Terminated
Recall details
- Recalling firm
- Toshiba American Med Sys Inc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 5
- Distribution
- Nationwide to AZ, CA, FL, MT, & PA
- Date initiated
- 2006-02-23
- Date posted
- 2006-03-29
- Date terminated
- 2012-02-29
- Location
- Tustin, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SMART SPOT (K961307) | Cmt Medical Technologies, Ltd. | 1996-07-01 |