Company:Toshiba American Medical Systems Inc.
Date of Enforcement Report: 10/21/2015
Class lI:
PRODUCT
Toshiba Aquilion CT System TSX-303A
Recall Number Z-0018-2016
REASON
it was found that if two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved.
RECALLING FIRM/MANUFACTURER
Toshiba American Medical Systems Inc., Tustin, CA on 5/8/2015 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
459
DISTRIBUTION
Nationwide and Puerto Rico
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