Reported Jan 27, 2021 · Ongoing
Synapse PACS Software Versions 5.1 and higher
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 Versions 5.1 and higher
- Lot codes and dates
Software Versions 5.15.25.35.45.5and 5.7
- Amount recalled
- 235
Where it was sold
- Nationwide
Why it was recalled
There is a potential for the wrong patient information may be displayed in the viewer or PowerJacket. Additionally, the incorrect max standard uptake values (SUV) for PET ad CT studies may be returned for Siemens Modality.
This product could cause temporary or reversible health problems — stop using it.
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