Company: Toshiba American Medical Systems Inc.
Date of Enforcement Report 10/14/2015
Celesteion PCA-9000A/2 PET/CT System
Recall Number Z-0005-2016
It was found that if specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved due to a software problem.
Toshiba American Medical Systems Inc, Tustin, CA on 5/8/2015. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE