Aquilion 64 CT System; Model number TSX-101 A/D The product is an x-ray device that uses digital geometry to generate a
FDA device recall Z-1165-2010 · posted 2010-03-19 · Terminated
Recall details
- Recalling firm
- Toshiba American Medical Systems Inc
- Reason for recall
- 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 taken
- 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.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 80
- Distribution
- Nationwide
- Date initiated
- 2009-01-08
- Date posted
- 2010-03-19
- Date terminated
- 2012-06-01
- Location
- Tustin, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TSX-101A/A AND TSX-101A/C AQUILION MULTISLICE CT SCANNERS (K033418) | Toshiba America Medical Systems, In.C | 2003-11-10 |