FDA Medical Device Recalls (openFDA)
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 number
- Z-0533-06
- Recalling firm
- Toshiba American Med Sys Inc
- Product
- Toshiba America Medical Systems, Ultimax System MDX-8000A equipped with the EPS-Plus/ADR-1000A/E2D Digital Spot Film Device
- Status
- Terminated
- Initiated
- 2006-02-23
- Posted
- 2006-03-29
- Terminated
- 2012-02-29
- 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
- Lot, serial or model codes
- Serial numbers: D4622390, D4622394, D4623349, D4612382, & D5512402
- 510(k) numbers
- ["K961307"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 2020563
- Firm city
- Tustin
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28