Hermes Medical Solutions AB is recalling approximately 778 units of its Hybrid Recon software, specifically versions 4.0.0x and 5.0.0 used on the Hermes Medical Imaging Suite version 6.1. The software has a potential configuration issue that can cause medical images from SPECT and CT scans to align incorrectly when they are being reconstructed. No incidents or injuries have been reported to date.
If SPECT and CT images are not aligned correctly, healthcare providers may receive inaccurate diagnostic information, which could lead to errors in treatment planning or patient diagnosis. The combined images might not properly reflect the patient's internal anatomy.
Quantity affected: 778 systems. Serial numbers are pending.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES ยท Raw API Response
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