Recall – Wrong patient info displayed due to software error

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

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