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Terminated

Aquilion 64 CT System; Model number TSX-101 A/H 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

FDA Recall Z-1167-2010 · Posted 2010-03-19

Recalling FirmToshiba American Medical Systems Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2009-01-08
Date Terminated2012-06-01
Product Quantity397

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.

Firm 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.

Root Cause

Component design/selection

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K080211MODEL TSX-101A/H/I AQUILION 32/64 SP CT SYSTEMToshiba America Medical Systems, In.C · 2008-03-14

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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