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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 9 of 9 Results
510(K) Number: K190232
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Product Description
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Recall
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FDA Recall
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Synapse PACS - Version 7.1.000US 2 03/07/2024 FUJIFILM Healthcare Americas Corporation
Synapse PACS - Version 7.2.200 2 03/07/2024 FUJIFILM Healthcare Americas Corporation
Synapse PACS - Version 7.2.100 2 03/07/2024 FUJIFILM Healthcare Americas Corporation
Synapse PACS - Version 7.1.000 2 03/07/2024 FUJIFILM Healthcare Americas Corporation
Synapse PACS - Version 7.3.000 2 03/07/2024 FUJIFILM Healthcare Americas Corporation
Synapse PACS - Version 7.2.000 2 03/07/2024 FUJIFILM Healthcare Americas Corporation
Synapse Cardiology PACS V7.3.0, V7.2, V7.1, V7.0. A web-based application as the primary user inte... 2 02/21/2024 FUJIFILM Healthcare Americas Corporation
FUJIFILM Synapse PACS Software: versions 7.0.0 and 7.0.1 - Product Usage: intended for use as a web... 2 01/22/2021 Fujifilm Medical Systems U.S.A., Inc.
Synapse PACS Software Version 5.6.1 - Product Usage: intended for use as a web based application on ... 2 10/22/2020 Fujifilm Medical Systems U.S.A., Inc.
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