FDA Medical Device Recalls (openFDA)
Toshiba American Med Sys Inc: Computed Tomography, Models TSX-101A and TSX-021A.
- Recall number
- Z-1031-04
- Recalling firm
- Toshiba American Med Sys Inc
- Product
- Computed Tomography, Models TSX-101A and TSX-021A.
- Status
- Terminated
- Initiated
- 2004-03-17
- Posted
- 2004-07-20
- Terminated
- 2011-11-01
- Reason
- Erroneous patient data is entered. Previoius patient's demographics are recorded.
- Root cause
- Software design
- Action
- Firm issued Field Modification Instruction which describes the action to be taken by the firm''s own service technicians. Recall letters were sent to each site informing of the issue and provide caution regarding the problem prior to it''s getting fixed.
- Quantity
- 552
- Distribution
- Nationwide.
- Lot, serial or model codes
- All Codes
- 510(k) numbers
- ["K982265","K982787"]
- PMA numbers
- not on file
- Product code
- JAK
- 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
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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