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Terminated

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

FDA Recall Z-1031-04 · Posted 2004-07-20

Recalling FirmToshiba American Med Sys Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2004-03-17
Date Terminated2011-11-01
Product Quantity552

Reason for Recall

Erroneous patient data is entered. Previoius patient's demographics are recorded.

Firm 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.

Root Cause

Software design

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K982787ASTEION CT SCANNER, TSX-021AToshiba America Medical Systems, In.C · 1998-10-21K982265AQUILION CT SCANNER, MODEL TSX-101AToshiba America Medical Systems, In.C · 1998-08-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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