Recall Z-1031-04 ยท JAK System, X-Ray, Tomography, Computed
Toshiba American Med Sys Inc
Computed Tomography, Models TSX-101A and TSX-021A.
| Date | Jul 20, 2004 (initiated Mar 17, 2004) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |