FDA Recall
Terminated
Aquilion 32 CT System; Model number TSX-101 A/K The product is an x-ray device that uses digital geometry to generate a three-dimensional image of the inside of an object from a large series of two-dimensional X-ray images take around a single axis of rotation
Recall: Z-1168-2010
·
Initiated January 8, 2009
Recall
- Recall Number
- Z-1168-2010
- Event Number
- 52825
- Firm
- Toshiba American Medical Systems Inc
- FEI Number
- 2020563
- Product Code
- JAK
- Status
- Terminated
- Root Cause
- Component design/selection
- Initiated
- January 8, 2009
- Posted
- March 19, 2010
- Terminated
- June 1, 2012
- Address
- 2441 Michelle Dr P.O. Box 2068, Tustin, CA, 92781-2068
Description
Aquilion 32 CT System; Model number TSX-101 A/K The product is an x-ray device that uses digital geometry to generate a three-dimensional image of the inside of an object from a large series of two-dimensional X-ray images take around a single axis of rotation
Reason
Toshiba America Medical Systems Inc (TAMS) has initiated a field correction on the Aquilion 32 CT Scanners due to the potential for the bolus tracking software (SureStart) to cause delay of the helical scan, up to 10 seconds, when large volumes of data are being reconstructed on the secondary console.
Action
Customer notification was sent and a software upgrade will be issued to all customers affected by the field correction. If you have questions, please call (800) 521-1968.
Distribution
Nationwide
Quantity
9