RecallDepth

Digital Radiography System Model DFP-8000D/FPD,

Company
Toshiba American Med Sys Inc
Recall Initiated
November 10, 2005
Posted
December 23, 2005
Terminated
February 5, 2007
Recall Number
Z-0325-06
Quantity
13
Firm Location
Tustin, CA

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.

Distribution

Nationwide

Lot / Code Info

Serial Numbers: B5522165 B4592121 B4602124 B4602126 W1B0542172 W1B0542174 B4582115 B4622147 B4572111 B5522161 B5512160 A4562105 B4582113

Root Cause

Other

Action Taken

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.

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