Hermes Medical Imaging Software May Cause Incorrect Image Reconstruction
Hermes Medical Solutions is recalling Hybrid Recon software (versions 4.0.0x and 5.0.0) due to a potential software configuration issue that may cause incorrect alignment during SPECT/CT image reconstruction. The issue affects 778 systems in the U.S. and internationally.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall with potential for diagnostic error due to software configuration issue. The hazard is theoretical with no reported illnesses or injuries, but the risk-of-harm nature of medical imaging software warrants high severity classification.
Plain-English summary
Hermes Medical Solutions AB is recalling Hybrid Recon software on Hermes Medical Imaging Suite version 6.1, specifically versions 4.0.0x and 5.0.0 of the Hybrid Recon software. A total of 778 systems are affected by this recall.
The software has a potential configuration issue that may result in incorrect alignment when reconstructing SPECT/CT (Single Photon Emission Computed Tomography/Computed Tomography) studies. Incorrect image alignment could potentially compromise the accuracy of medical imaging and diagnosis.
The affected systems have been distributed in the United States in California, Connecticut, Florida, Hawaii, Kentucky, Massachusetts, Maryland, Missouri, New Jersey, New York, Ohio, Tennessee, Texas, Virginia, and Washington, as well as internationally in Germany and the United Kingdom.
Healthcare facilities using the affected software versions should contact Hermes Medical Solutions AB regarding this recall and obtain guidance on addressing this issue. Clinicians should be aware of the potential for incorrect image reconstruction when using the affected software versions.
The recalled product
- Product
- Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Recon software versions affected are 4.0.0x and 5.0.0
- Manufacturer
- Hermes Medical Solutions AB
- Affected units
- 778
Distribution
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