Z-0533-06

Toshiba America Medical Systems, Ultimax System MDX-8000A equipped with the EPS-Plus/ADR-1000A/E2D Digital...

Name: Z-0533-06 Toshiba America Medical Systems, Ultimax System MDX-8000A equipped with the EPS-Plus/ADR-1000A/E2D Digital...
Creator: Toshiba American Med Sys Inc
Published: 2006-02-23
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2006-02-23 / Terminated

FDA source

Toshiba American Med Sys Inc began a recall of Toshiba America Medical Systems, Ultimax System MDX-8000A equipped with the EPS-Plus/ADR-1000A/E2D Digital Spot Film Device on 2006-02-23. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0533-06
Status: Terminated
Initiated: 2006-02-23
Posted: 2006-03-29
Terminated: 2012-02-29
Recalling firm: Canon Medical Systems USA, Inc.
Product: Toshiba America Medical Systems, Ultimax System MDX-8000A equipped with the EPS-Plus/ADR-1000A/E2D Digital Spot Film Device
Product code: LLZ System, Image Processing, Radiological
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.
FDA 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 in commerce: 5
Distribution: Nationwide to AZ, CA, FL, MT, & PA
Product codes and lots: Serial numbers: D4622390, D4622394, D4623349, D4612382, & D5512402

Product code LLZ

K961307Class IISmart SpotCmt Medical Technologies, Ltd. / cleared 1996-07-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)