Toshiba America Medical Systems (TAMS) Aquilion 64 CT system, computed tomography x-ray system.
FDA Recall Z-1708-2008 · 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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.