Fujifilm Medical Systems U.S.A., Inc. recalls Fujifilm Synapse PACS, Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx Medical imaging and inform…
- Recall date
- September 15, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0073-2017
- FDA classification
- Class II
- Brand / firm
- Fujifilm Medical Systems U.S.A., Inc.
- Sold / distributed
- US Nationwide Distribution.
Why it was recalled
Image data for a patients image may not be correct
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Fujifilm Synapse PACS, Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx Medical imaging and information management system, SYNAPSE allows the archiving and distribution of image information from all modalities
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