Company:Toshiba American Medical Systems Inc.
Date of Enforcement Report 3/21/12
Class ll:

PRODUCT
1) TSX-301A: AQUILION ONE; System, X-Ray, Tomography. Aquilion One is a multislice CT system that supports whole body scanning. The system supports simultaneous data aquisition of 320 slices using the Selectable Slice-thickness Multi-row Detector (SSMD). In addition, the high speed rotation mechanism and the reconstruction unit of the system allow quick image acquisition to further improve throughput in CT examinations. Aquilion ONE, Toshiba’s top of the line X-ray CT system, is provided with a 7.5 MHU large capacity X-ray tube unit and detector and permits scanning at the high speed per rotation. Recall # Z-1034-2012;

2) TSX-301B: AQUILION ONE; System, X-Ray, Tomography. Aquilion One is a multislice CT system that supports whole body scanning. The system supports simultaneous data aquisition of 320 slices using the Selectable Slice-thickness Multi-row Detector (SSMD). In addition, the high speed rotation mechanism and the reconstruction unit of the system allow quick image acquisition to further improve throughput in CT examinations. Aquilion ONE, Toshiba’s top of the line X-ray CT system, is provided with a 7.5 MHU large capacity X-ray tube unit and detector and permits scanning at the high speed per rotation. Recall # Z-1034-2012;

REASON
The recall was initiated because Toshiba has confirmed that there is a potential software issue for the TSX-301A Aquilon One and the TSX-301B Aquilon One.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Toshiba American Medical Systems Inc., Tustin, CA, by letter on January 3, 2012.
Manufacturer: Toshiba Medical Systems Co., Tochigi-Ken, Japan. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
82 units

DISTRIBUTION
Nationwide and Puerto Rico

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