Aquilion One: Aquilion TSX-301A, 64 System, X-Ray, Tomography. Toshiba American Medical Systems, Inc. A multislice CT system that supports whole-body scanning.
FDA Recall Z-2895-2011 · Posted 2011-07-29
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Recalling FirmToshiba American Medical Systems Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2011-01-07
Date Terminated2012-08-17
Product Quantity6
Reason for Recall
Toshiba America Medical Systems (TAMS) is initiating a field correction for the TSX-301A and TSX-301B: Aquilion 64 System, X-Ray, Tomography because communication between reconstruction units in the system console may be broken due to failure of the optical conversion connector, resulting in a break of communication between units.
Firm Action
Toshiba America Medical Systems, Inc. sent an "Urgent Medical Device Correction" letter dated January 4, 2011 to all affected customers.
The letter provides the customers with an explanation of the problem and the firms plan to install preventive measures and provided them with a Customer Reply form to send Toshiba. A representative will contact the customers for an appointment to install the measures to their CT system.
For question on this recall call (800) 421-1968 or contact your local Toshiba Representative at (800) 521-1968.
Root Cause
Software design
Distribution Pattern
(USA) Nationwide Distribution including the states of WI, MO, TN, IA, AL, AZ, TX, and GA.
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.
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