Reported Mar 13, 2024 · Ongoing
Synapse PACS - Version 7.3.000
FUJIFILM Healthcare Americas Corporation
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 Healthcare Americas Corporation · 81 Hartwell Ave Ste 300 · Lexington, MA · 02421-3160
Is this the product you have?
- Synapse PACS - Version 7.3.000
- Lot codes and dates
- Software Version7.3.000
- UDI(01)854904006008(10)0703000
- Amount recalled
- 64 Units (44 US, 20 OUS)
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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