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Terminated

Toshiba Digital Radiography System Model DFP8000D

FDA Recall Z-0532-06 · Posted 2006-02-23

Recalling FirmToshiba American Med Sys Inc
Recall StatusTerminated
Product CodeJAA
Date Initiated2005-11-15
Date Terminated2007-07-12
Product Quantity3

Reason for Recall

In certain conditions the FOV of the lateral plane does not coincide with the X-ray exposed area, and consequently a part of the X-ray field may not be displayed in the magnification mode.

Firm Action

An Advisory Letter will be sent to customers via certified mail. Corrected software will be provided at no charge. Customers can contact their local Toshiba Service person to schedule the software update.

Root Cause

Other

Distribution Pattern

CO, MI, & TX

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K013608DIGITAL RADIOGRAPHY SYSTEM, MODEL DFP-8000DToshiba America Medical Systems, In.C · 2001-11-15

Official Source

View FDA Recall →

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

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