Reported Oct 28, 2020 · Terminated
Synapse PACS Software Version 5.6.1 - Product Usage: intended for use as a web based application on an off-the shelf PC…
Fujifilm Medical Systems U.S.A., Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fujifilm Medical Systems U.S.A., Inc. · 81 Hartwell Ave Ste 300 · Lexington, MA · 02421-3160
Is this the product you have?
- Synapse PACS Software Version 5.6.1 -
- Product Usageintended 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
- Lot codes and dates
- Synapse Software Version 5.6.1
- Amount recalled
- 1
Where it was sold
- Nationwide
- MN
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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