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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Hermes Hybrid Recon Software Recalled for Incorrect SPECT/CT Image Alignment

Agency Publication Date: December 12, 2024
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Summary

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.

Risk

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.

What You Should Do

  1. This recall affects Hybrid Recon software versions 4.0.0x and 5.0.0 installed as part of the Hermes Medical Imaging Suite version 6.1.
  2. Check your system configuration or contact your IT department to determine if your software uses UDI-DI codes 00859873006158 or (01)00859873006196(8012)005000000.
  3. Stop using the recalled software for reconstructing SPECT/CT studies until a correction has been applied.
  4. Contact Hermes Medical Solutions AB or your equipment distributor to arrange for a software update or configuration correction.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this recall or to report any device-related issues.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Hybrid Recon software on Hermes Medical Imaging Suite (version 6.1)
Variants: Version 4.0.0x, Version 5.0.0
Model / REF:
4.0.0x
5.0.0
Lot Numbers:
00859873006158
UDI:
00859873006158
(01)00859873006196(8012)005000000

Quantity affected: 778 systems. Serial numbers are pending.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95673
Status: Active
Manufacturer: Hermes Medical Solutions AB
Sold By: Direct sales; Authorized medical device distributors
Manufactured In: Sweden
Units Affected: 778 systems
Distributed To: California, Connecticut, Florida, Hawaii, Kentucky, Massachusetts, Maryland, Missouri, New Jersey, New York, Ohio, Tennessee, Texas, Virginia, Washington

Were You Affected by This Recall?

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.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.