Synapse PACS Software Version 5.6.1 - Product Usage: intended for use as a web based application on an off-the shelf PC which meets or exceeds minimum specifications and is networked with a FUJIFILM Synapse PACS server.
FDA Recall Z-0282-2021 · Posted None
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Recalling FirmFujifilm Medical Systems U.S.A., Inc.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2020-09-11
Date Terminated2021-11-17
Product Quantity1
Reason for Recall
FUJIFILM has become aware of the possibility that certain CT studies may report a much higher 3D Sphere MAX value than expected. This issue is specific to 3D Sphere - other density tools are not affected.
Firm Action
Letter was sent to all affected customers on 09/11/2020 stating the following: FUJIFILM will offer an upgrade to Synapse PACS 7.1.100 to resolve this issue. Synapse PACS 7.1.100 is estimated to be available by the end of September.
Until the patch is available, users can continue to safely use Synapse PACS by following these additional instructions:
1. Ensure that the 3D Sphere MAX value is within the spheres range. If the 3D Sphere MAX value is observed to be much higher than expected, the value should not be used when rendering a clinical decision until the issue is corrected.
Customers should complete and return the Field Action Verification Form attached to the recall letter.
Root Cause
Software change control
Distribution Pattern
US Nationwide distribution including in the state of Minnesota.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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