Cl II Toshiba Celesteion PCA-9000A/2 PET/CT

Company: Toshiba American Medical Systems Inc.
Date of Enforcement Report 10/14/2015
Class lI:

PRODUCT

Celesteion PCA-9000A/2 PET/CT System
Recall Number Z-0005-2016

REASON
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.

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
1

DISTRIBUTION
Nevada

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