Fujifilm Medical Systems U.S.A., Inc. recalls Synapse PACS Software Versions 5.1 and higher
- Recall date
- September 11, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0878-2021
- FDA classification
- Class II
- Brand / firm
- Fujifilm Medical Systems U.S.A., Inc.
- Sold / distributed
- Software was distributed to medical facilities nationwide throughout the U.S.
Why it was recalled
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Synapse PACS Software Versions 5.1 and higher
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