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Terminated

Digital Radiography System Model DFP8000D

FDA Recall Z-0324-06 · Posted 2005-12-23

Recalling FirmToshiba American Med Sys Inc
Recall StatusTerminated
Product CodeJAA
Date Initiated2005-11-10
Date Terminated2007-02-05
Product Quantity72

Reason for Recall

To correct a software problem that caused the LV images, which were acquired for 15 seconds at the end of the examination, to be lost.

Firm Action

An Advisory Letter was sent to the customers via certified mail. Toshiba issued a Field Modification Instruction (FMI XRA29-90828) to correct that software bug and bring the DFP-8000D into compliance. The FMI is provided to the customers at no charge.

Root Cause

Other

Distribution Pattern

Nationwide

Official Source

View FDA Recall →

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

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