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Terminated

Toshiba America Medical Systems (TAMS) Aquilion 32 CT system, computed tomography x-ray system.

FDA Recall Z-1707-2008 · Posted 2008-09-29

Recalling FirmToshiba American Med Sys Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2007-10-01
Date Terminated2012-07-16
Product Quantity1203 total

Reason for Recall

Excessive radiation: Intermittent shifting of CT numbers causes the actual dose to the patient to be greater than expected, when Sure Exposure option is used.

Firm Action

Toshiba sent a letter to customers in July 2007, and sent field service representatives to update the Data Aquisition System in September/October 2007.

Root Cause

Device Design

Distribution Pattern

Worldwide distribution, including USA and Japan.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K982265AQUILION 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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