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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Toshiba America Medical Systems, Ultimax System MDX-8000A equipped with the EPS-Plus/ADR-1000A/E2D Digital Spot Film Device
Brand
Toshiba American Med Sys Inc
Lot Codes / Batch Numbers
Serial numbers: D4622390, D4622394, D4623349, D4612382, & D5512402
Products Sold
Serial numbers: D4622390, D4622394, D4623349, D4612382, & D5512402
Toshiba American Med Sys Inc is recalling Toshiba America Medical Systems, Ultimax System MDX-8000A equipped with the EPS-Plus/ADR-1000A/E2D D due to When the error condition occurs the x-ray exposures will terminate immediately. The digital system (EPS-Plus/ADR-1000A) will immediately stop acquiri. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026