Company: Toshiba America Medical Systems, Inc
Date of Enforcement Report 10/12/2016
Class lI:
PRODUCT
Toshiba America Medical Systems, Inc . Aquilion LB TSX-201A/2, 3 CT Scanner
Recall Number Z-0048-2017
REASON
It has been found that if the scan range extends beyond the maximum Field of View (FOV), a reconstruction operation error may occur. As a result, scanning may be interrupted and rebooting of the system may be necessary. Please note that this issue has not occurred in the U.S.
RECALLING FIRM/MANUFACTURER
Toshiba America Medical Systems, Inc., Tustin, CA on 10/6/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
165
DISTRIBUTION
Nationwide
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