Company:Toshiba American Medical Systems Inc.
Date of Enforcement Report 9/5/12
Class ll:
PRODUCT
Whole Body X–ray Scanner This device is indicated as a whole body volume CT system. The system produces volumes of up to 320 axial slices in a single rotation. Z-2282-2012
REASON
1. It has been found that in raw data processing for Go&Return helical scanning, when the raw data acquired in the first scan (Go) and that acquired in the second scan (Return) are selected and reconstructed at one time, incorrect couch positions and scan times are displayed on the reconstructed images for the data acquired by Return scanning, while all related information is displayed on the reconstructed images for the data acquired by Go scanning. This phenomenon is due to a problem in the image reconstruction software. It should be noted that this error occurs, the error does not occur for in-scan reconstructed images or images obtained by selecting and reconstructing the acquired raw data for each scan individually after scanning is completed. 2. It has been found that when scanning is performed while the tube current is modulated (Sure Exposure 3D), a transmission of the modulation data to X-ray control section may fail due to a hardware problem, and an error occurs at the time of scan setup as a result. If this error occurs at the time of scan setup as a result. If this error occurs, the error message shown in the figure on the right is displayed on the monitor and the eXam Plan is interrupted. In addition, if this error occurs in an eXam Plan in which Sure Exposure 3D is selected as the actual scan for SureStart, the right error message is displayed after monitoring scan. Monitoring scan therefore cannot be switched to the actual scan and the eXam Plan is interrupted as a result. It should be noted that this error does not occur when the tube current is modulated in ECG synchronization.
RECALLING FIRM/MANUFACTURER
Toshiba American Medical Systems Inc.,Tustin, CA on 7/13/2009. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
24 Systems
DISTRIBUTION
Nationwide
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