Reported Mar 26, 2025 · Ongoing
Synapse PACS Software Version 7.4.x; Software Versions: 7.4.000, 7.4.001, 7.4.010, 7.4.100, 7.4.110, 7.4.200.
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 Software Version 7.4.x
- Software Versions
7.4.0007.4.0017.4.0107.4.1007.4.1107.4.200
- Lot codes and dates
6 of 6 products
Products covered by this recall # Barcodes Product as published 1 00854904006008Model numbers: Synapse PACS 7.4.000, 7.4.001, 7.4.010, 7.4.100, 7.4.110, 7.4.200 Software Version Numbers: Synapse PACS 7.4.000, UDI: (01)00854904006008(10)0704000 2 00854904006008Synapse PACS 7.4.001, UDI: (01)00854904006008(10)0704001 3 00854904006008Synapse PACS 7.4.010, UDI: (01)00854904006008(10)0704010 4 00854904006008Synapse PACS 7.4.100, UDI: (01)00854904006008(10)0704100 5 00854904006008Synapse PACS 7.4.110, UDI: (01)00854904006008(10)0704110 6 00854904006008Synapse PACS 7.4.200, UDI: (01)00854904006008(10)0704200. - Amount recalled
- 104 units (69 US, 35 OUS)
Where it was sold
Why it was recalled
The incorrect computed patient age is showing in VX for patients less than 3 months old.
This product could cause temporary or reversible health problems — stop using it.
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