Reported Dec 18, 2024 · Ongoing
Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Recon software versions affected are 4.0.0x…
Hermes Medical Solutions AB
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: Hermes Medical Solutions AB · Strandbergsgatan 16 · Stockholm · N/A
Is this the product you have?
- Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Recon software versions affected are 4.0.0x and 5.0.0
- Lot codes and dates
- Hermes Medical Imaging System version 6.1 with Hybrid Recon version 4.0
- x UDI-DI code00859873006158
- Serial NumbersPending Hybrid Recon version 5.0.0
- UDI code(01)00859873006196(8012)005000000
- Serial NumbersPending
- Amount recalled
- 778 systems
Where it was sold
Why it was recalled
Due a potential software/configuration issue that may result is incorrect alignment during reconstructing a SPECT/CT study.
This product could cause temporary or reversible health problems — stop using it.
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