Company:Blood Bank Computer Systems, Inc .
Date of Enforcement Report 4/17/2013
Class ll:
PRODUCT
Toshiba TSX-30IC AQUlLlON ONE System, Computed Tomography X-Ray. This system supports Whole body scanning. Recall Number Z-1068-2013
REASON
It has been found that due to a problem with the control software of the x-ray high-voltage generator, if scanning is performed with a tube current less than 30mA, the control software may detect an error and perform error processing even though the x-ray output is normal.
RECALLING FIRM/MANUFACTURER
Toshiba American Medical Systems Inc, Tustin, CA, on 11/14/2012. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1
DISTRIBUTION
State of MD
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