Z-1031-04

Computed Tomography, Models TSX-101A and TSX-021A

Name: Z-1031-04 Computed Tomography, Models TSX-101A and TSX-021A
Creator: Toshiba American Med Sys Inc
Published: 2004-03-17
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2004-03-17 / Terminated / root cause: software

FDA source

Toshiba American Med Sys Inc began a recall of Computed Tomography, Models TSX-101A and TSX-021A on 2004-03-17. The reason FDA records is "Erroneous patient data is entered. Previoius patient's demographics are recorded". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1031-04
Status: Terminated
Initiated: 2004-03-17
Posted: 2004-07-20
Terminated: 2011-11-01
Recalling firm: Canon Medical Systems USA, Inc.
Product: Computed Tomography, Models TSX-101A and TSX-021A.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Erroneous patient data is entered. Previoius patient's demographics are recorded.
Root cause tag: software
FDA 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 in commerce: 552
Distribution: Nationwide.
Product codes and lots: All Codes

Product code JAK

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)