Company: Fujifilm Medical Systems U.S.A., Inc.
Date of Enforcement Report: 1/27/2021
Class II
PRODUCT
Synapse PACS Software Versions 5.1 and higher
Recall Number: Z-0878-2021
REASON
There is a potential for the wrong patient information may be displayed in the viewer or PowerJacket. Additionally, the incorrect max standard uptake values (SUV) for PET ad CT studies may be returned for Siemens Modality.
RECALLING FIRM/MANUFACTURER
Fujifilm Medical Systems U.S.A., Inc. on 9/11/2020. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
235
DISTRIBUTION
U.S. Nationwide