Enforcement Report - Week of September 5, 2012
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Product Detail
| Product Description | Toshiba CT systems, Asteion and Aquilion, that are equipped with a PC based computer, or to those older systems (SGI based) that received an improved table by an upgrade purchase. This device is designed to produce cross-sectional images of a human body by reconstruction of xray transmission data from the same axial plane taken at different angles. These images have been proven to be clinically useful in the diagnosis of spine and head injuries, intracranial tumors, blood clots in the brain, eye trauma, soft tissue lesions in the extremities, gastrointestinal lesions, abdominal and pelvic malignancies, and hepatic metastases. CT is also used to evaluate intestinal obstruction!;, assess intra-abdominal abnormalities and to examine musculoskeletal degeneration. This device employs no intended uses that are not in cleared devices already found in the marketplace. |
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| Recall Number | Z-2266-2012 |
| Classification | Class II |
| Code Info | Serial Number Range (last 4): (2665-3149), (2211-2237), (2057-2067), A3622041, A4582122 + (2690-3131), (2001-2171), (2001-2124), (2001-2255), (2001-3007), (2015-2061), (2001-2008). The following Device Name/Model Number: Asteion Super 4 / TSX-021B Aquilion Super 4 / TSX-101A/7 Aquilion 8 / TSX-101A/F Aqui1ion 16/ TSX-101A/6 Aqui1ion 16/ TSX-101A/G Aquilion 32 / TSX-101A/D Aquilion 32 / TSX-101A/I Aquilion 64/TSX-101A/E Aquilion 64 / TSX-101AIH Aquilion 16 LB / TSX-201A AquilionONE / TSX-301A |
| Product Distributed Qty | 757 |
| Reason For Recall | The systems all have a similar table control board. It has been found that this board may cause the table position to be incorrect if the table cradle is moved manually. This is referred to as "Free" mode in the operation manuals. If this error does occur it is possible that the patient could be scanned at an incorrect position. |
Event Detail
| Event Id | 62851 |
|---|---|
| Product Type | Devices |
| Status | Completed |
| Recalling Firm | Toshiba American Medical Systems Inc |
| City | Tustin |
| State | CA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2008-02-27 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | USA ( Nationwide Distribution ) |
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