Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0282-2021 — 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.

U.S. FDA — Device Enforcement · United States · 2020-09-11 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0282-2021
Date of alert
2020-09-11
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Fujifilm Medical Systems U.S.A., Inc.
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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